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[A1]
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Electronic Code of Federal Regulations
| e-CFR data is current as of December 12, 2019
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBCHAPTER H—MEDICAL DEVICES PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES
Subpart A—GENERAL PROVISIONS
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| Effective dates of requirement for premarket approval. |
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| Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). |
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Subpart B—[RESERVED]
Subpart C—GENERAL HOSPITAL AND PERSONAL USE MONITORING DEVICES
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| Liquid crystal forehead temperature strip. |
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| Electronic monitor for gravity flow infusion systems. |
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| Electrically powered spinal fluid pressure monitor. |
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| Image processing device for estimation of external blood loss. |
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| Sterilization process indicator. |
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| Clinical color change thermometer. |
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| Clinical electronic thermometer. |
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| Clinical mercury thermometer. |
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Subparts D-E [Reserved]
Subpart F—GENERAL HOSPITAL AND PERSONAL USE THERAPEUTIC DEVICES
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| Medical recirculating air cleaner. |
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| AC-powered adjustable hospital bed. |
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| Hydraulic adjustable hospital bed. |
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| Manual adjustable hospital bed. |
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| Nonpowered flotation therapy mattress. |
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| Therapeutic medical binder. |
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| Intravascular catheter securement device. |
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| Medical adhesive tape and adhesive bandage. |
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| Neonatal transport incubator. |
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| Pressure infusor for an I.V. bag. |
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| Nonelectrically powered fluid injector. |
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| Intravascular administration set. |
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| Intravascular administration set, automated air removal system. |
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| Patient care reverse isolation chamber. |
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| Non-AC-powered patient lift. |
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| Alternating pressure air flotation mattress. |
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| Temperature regulated water mattress. |
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| Hypodermic single lumen needle. |
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| Pediatric position holder. |
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| Neonatal phototherapy unit. |
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| Chemical cold pack snakebite kit. |
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| Medical support stocking. |
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| Therapeutic scrotal support. |
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| Umbilical occlusion device. |
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| Subcutaneous, implanted, intravascular infusion port and catheter. |
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| Percutaneous, implanted, long-term intravascular catheter. |
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Subpart G—GENERAL HOSPITAL AND PERSONAL USE MISCELLANEOUS DEVICES
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| Absorbent tipped applicator. |
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| Medical disposable bedding. |
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| Cardiopulmonary resuscitation board. |
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| Ethylene oxide gas aerator cabinet. |
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| Ultrasonic cleaner for medical instruments. |
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| Mattress cover for medical purposes. |
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| Sharps needle destruction device. |
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| Non-powdered patient examination glove. |
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| Filtering facepiece respirator for use by the general public in public health medical emergencies. |
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| Implantable radiofrequency transponder system for patient identification and health information. |
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| Medical device data system. |
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| Remote Medication Management System. |
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| AC-powered medical examination light. |
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| Battery-powered medical examination light. |
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| Liquid medication dispenser. |
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| Skin pressure protectors. |
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| Medical ultraviolet air purifier. |
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| Ultraviolet (UV) radiation chamber disinfection device. |
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| Medical ultraviolet water purifier. |
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| Vacuum-powered body fluid suction apparatus. |
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| Powered patient transfer device. |
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| Manual patient transfer device. |
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| Washers for body waste receptacles. |
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| Medical disposable scissors. |
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| Ethylene oxide gas sterilizer. |
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| Liquid chemical sterilants/high level disinfectants. |
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| General purpose disinfectants. |
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| Syringe needle introducer. |
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| Liquid crystal vein locator. |
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| Medical washer-disinfector. |
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