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Electronic Code of Federal Regulations

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e-CFR Data is current as of October 22, 2014

Title 21Chapter ISubchapter HPart 868


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 868—ANESTHESIOLOGY DEVICES

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Subpart A—GENERAL PROVISIONS

§868.1
Scope.
§868.3
Effective dates of requirement for premarket approval.
§868.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B—DIAGNOSTIC DEVICES

§868.1030
Manual algesimeter.
§868.1040
Powered algesimeter.
§868.1075
Argon gas analyzer.
§868.1100
Arterial blood sampling kit.
§868.1120
Indwelling blood oxyhemoglobin concentration analyzer.
§868.1150
Indwelling blood carbon dioxide partial pressure (PCO2) analyzer.
§868.1170
Indwelling blood hydrogen ion concentration (pH) analyzer.
§868.1200
Indwelling blood oxygen partial pressure (PO2) analyzer.
§868.1400
Carbon dioxide gas analyzer.
§868.1430
Carbon monoxide gas analyzer.
§868.1500
Enflurane gas analyzer.
§868.1575
Gas collection vessel.
§868.1620
Halothane gas analyzer.
§868.1640
Helium gas analyzer.
§868.1670
Neon gas analyzer.
§868.1690
Nitrogen gas analyzer.
§868.1700
Nitrous oxide gas analyzer.
§868.1720
Oxygen gas analyzer.
§868.1730
Oxygen uptake computer.
§868.1750
Pressure plethysmograph.
§868.1760
Volume plethysmograph.
§868.1780
Inspiratory airway pressure meter.
§868.1800
Rhinoanemometer.
§868.1840
Diagnostic spirometer.
§868.1850
Monitoring spirometer.
§868.1860
Peak-flow meter for spirometry.
§868.1870
Gas volume calibrator.
§868.1880
Pulmonary-function data calculator.
§868.1890
Predictive pulmonary-function value calculator.
§868.1900
Diagnostic pulmonary-function interpretation calculator.
§868.1910
Esophageal stethoscope.
§868.1920
Esophageal stethoscope with electrical conductors.
§868.1930
Stethoscope head.
§868.1965
Switching valve (ploss).
§868.1975
Water vapor analyzer.
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Subpart C—MONITORING DEVICES

§868.2025
Ultrasonic air embolism monitor.
§868.2300
Bourdon gauge flowmeter.
§868.2320
Uncompensated thorpe tube flowmeter.
§868.2340
Compensated thorpe tube flowmeter.
§868.2350
Gas calibration flowmeter.
§868.2375
Breathing frequency monitor.
§868.2377
Apnea monitor.
§868.2380
Nitric oxide analyzer.
§868.2385
Nitrogen dioxide analyzer.
§868.2450
Lung water monitor.
§868.2480
Cutaneous carbon dioxide (PcCO2) monitor.
§868.2500
Cutaneous oxygen (PcO2) monitor.
§868.2550
Pneumotachometer.
§868.2600
Airway pressure monitor.
§868.2610
Gas pressure gauge.
§868.2620
Gas pressure calibrator.
§868.2700
Pressure regulator.
§868.2775
Electrical peripheral nerve stimulator.
§868.2875
Differential pressure transducer.
§868.2885
Gas flow transducer.
§868.2900
Gas pressure transducer.
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Subparts D-E [Reserved]

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Subpart F—THERAPEUTIC DEVICES

§868.5090
Emergency airway needle.
§868.5100
Nasopharyngeal airway.
§868.5110
Oropharyngeal airway.
§868.5115
Device to relieve acute upper airway obstruction.
§868.5120
Anesthesia conduction catheter.
§868.5130
Anesthesia conduction filter.
§868.5140
Anesthesia conduction kit.
§868.5150
Anesthesia conduction needle.
§868.5160
Gas machine for anesthesia or analgesia.
§868.5165
Nitric oxide administration apparatus.
§868.5170
Laryngotracheal topical anesthesia applicator.
§868.5180
Rocking bed.
§868.5220
Blow bottle.
§868.5240
Anesthesia breathing circuit.
§868.5250
Breathing circuit circulator.
§868.5260
Breathing circuit bacterial filter.
§868.5270
Breathing system heater.
§868.5280
Breathing tube support.
§868.5300
Carbon dioxide absorbent.
§868.5310
Carbon dioxide absorber.
§868.5320
Reservoir bag.
§868.5330
Breathing gas mixer.
§868.5340
Nasal oxygen cannula.
§868.5350
Nasal oxygen catheter.
§868.5365
Posture chair for cardiac or pulmonary treatment.
§868.5375
Heat and moisture condenser (artificial nose).
§868.5400
Electroanesthesia apparatus.
§868.5420
Ether hook.
§868.5430
Gas-scavenging apparatus.
§868.5440
Portable oxygen generator.
§868.5450
Respiratory gas humidifier.
§868.5460
Therapeutic humidifier for home use.
§868.5470
Hyperbaric chamber.
§868.5530
Flexible laryngoscope.
§868.5540
Rigid laryngoscope.
§868.5550
Anesthetic gas mask.
§868.5560
Gas mask head strap.
§868.5570
Nonrebreathing mask.
§868.5580
Oxygen mask.
§868.5590
Scavenging mask.
§868.5600
Venturi mask.
§868.5610
Membrane lung for long-term pulmonary support.
§868.5620
Breathing mouthpiece.
§868.5630
Nebulizer.
§868.5640
Medicinal nonventilatory nebulizer (atomizer).
§868.5650
Esophageal obturator.
§868.5655
Portable liquid oxygen unit.
§868.5665
Powered percussor.
§868.5675
Rebreathing device.
§868.5690
Incentive spirometer.
§868.5700
Nonpowered oxygen tent.
§868.5710
Electrically powered oxygen tent.
§868.5720
Bronchial tube.
§868.5730
Tracheal tube.
§868.5740
Tracheal/bronchial differential ventilation tube.
§868.5750
Inflatable tracheal tube cuff.
§868.5760
Cuff spreader.
§868.5770
Tracheal tube fixation device.
§868.5780
Tube introduction forceps.
§868.5790
Tracheal tube stylet.
§868.5795
Tracheal tube cleaning brush.
§868.5800
Tracheostomy tube and tube cuff.
§868.5810
Airway connector.
§868.5820
Dental protector.
§868.5830
Autotransfusion apparatus.
§868.5860
Pressure tubing and accessories.
§868.5870
Nonrebreathing valve.
§868.5880
Anesthetic vaporizer.
§868.5895
Continuous ventilator.
§868.5905
Noncontinuous ventilator (IPPB).
§868.5915
Manual emergency ventilator.
§868.5925
Powered emergency ventilator.
§868.5935
External negative pressure ventilator.
§868.5955
Intermittent mandatory ventilation attachment.
§868.5965
Positive end expiratory pressure breathing attachment.
§868.5975
Ventilator tubing.
§868.5995
Tee drain (water trap).
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Subpart G—MISCELLANEOUS

§868.6100
Anesthetic cabinet, table, or tray.
§868.6175
Cardiopulmonary emergency cart.
§868.6225
Nose clip.
§868.6250
Portable air compressor.
§868.6400
Calibration gas.
§868.6700
Anesthesia stool.
§868.6810
Tracheobronchial suction catheter.
§868.6820
Patient position support.
§868.6885
Medical gas yoke assembly.


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