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Electronic Code of Federal Regulations

e-CFR data is current as of December 5, 2019

Title 21Chapter ISubchapter HPart 882


TITLE 21—Food and Drugs

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

SUBCHAPTER H—MEDICAL DEVICES

PART 882—NEUROLOGICAL DEVICES

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Subpart A—GENERAL PROVISIONS

§882.1
Scope.
§882.3
Effective dates of requirement for premarket approval.
§882.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B—NEUROLOGICAL DIAGNOSTIC DEVICES

§882.1020
Rigidity analyzer.
§882.1030
Ataxiagraph.
§882.1200
Two-point discriminator.
§882.1240
Echoencephalograph.
§882.1275
Electroconductive media.
§882.1310
Cortical electrode.
§882.1320
Cutaneous electrode.
§882.1330
Depth electrode.
§882.1340
Nasopharyngeal electrode.
§882.1350
Needle electrode.
§882.1400
Electroencephalograph.
§882.1410
Electroencephalograph electrode/lead tester.
§882.1420
Electroencephalogram (EEG) signal spectrum analyzer.
§882.1430
Electroencephalograph test signal generator.
§882.1440
Neuropsychiatric interpretive electroencephalograph assessment aid.
§882.1450
Brain injury adjunctive interpretive electroencephalograph assessment aid.
§882.1460
Nystagmograph.
§882.1470
Computerized cognitive assessment aid.
§882.1471
Computerized cognitive assessment aid for concussion.
§882.1480
Neurological endoscope.
§882.1500
Esthesiometer.
§882.1525
Tuning fork.
§882.1540
Galvanic skin response measurement device.
§882.1550
Nerve conduction velocity measurement device.
§882.1560
Skin potential measurement device.
§882.1561
Evoked photon image capture device.
§882.1570
Powered direct-contact temperature measurement device.
§882.1580
Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.
§882.1610
Alpha monitor.
§882.1620
Intracranial pressure monitoring device.
§882.1630
Cranial motion measurement device.
§882.1700
Percussor.
§882.1750
Pinwheel.
§882.1790
Ocular plethysmograph.
§882.1825
Rheoencephalograph.
§882.1835
Physiological signal amplifier.
§882.1845
Physiological signal conditioner.
§882.1855
Electroencephalogram (EEG) telemetry system.
§882.1870
Evoked response electrical stimulator.
§882.1880
Evoked response mechanical stimulator.
§882.1890
Evoked response photic stimulator.
§882.1900
Evoked response auditory stimulator.
§882.1925
Ultrasonic scanner calibration test block.
§882.1935
Near Infrared (NIR) Brain Hematoma Detector.
§882.1950
Tremor transducer.
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Subparts C-D [Reserved]

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Subpart E—NEUROLOGICAL SURGICAL DEVICES

§882.4030
Skull plate anvil.
§882.4060
Ventricular cannula.
§882.4100
Ventricular catheter.
§882.4125
Neurosurgical chair.
§882.4150
Scalp clip.
§882.4175
Aneurysm clip applier.
§882.4190
Clip forming/cutting instrument.
§882.4200
Clip removal instrument.
§882.4215
Clip rack.
§882.4250
Cryogenic surgical device.
§882.4275
Dowel cutting instrument.
§882.4300
Manual cranial drills, burrs, trephines, and their accessories
§882.4305
Powered compound cranial drills, burrs, trephines, and their accessories.
§882.4310
Powered simple cranial drills, burrs, trephines, and their accessories.
§882.4325
Cranial drill handpiece (brace).
§882.4360
Electric cranial drill motor.
§882.4370
Pneumatic cranial drill motor.
§882.4400
Radiofrequency lesion generator.
§882.4440
Neurosurgical headrests.
§882.4460
Neurosurgical head holder (skull clamp).
§882.4500
Cranioplasty material forming instrument.
§882.4525
Microsurgical instrument.
§882.4535
Nonpowered neurosurgical instrument.
§882.4545
Shunt system implantation instrument.
§882.4560
Stereotaxic instrument.
§882.4600
Leukotome.
§882.4650
Neurosurgical suture needle.
§882.4700
Neurosurgical paddie.
§882.4725
Radiofrequency lesion probe.
§882.4750
Skull punch.
§882.4800
Self-retaining retractor for neurosurgery.
§882.4840
Manual rongeur.
§882.4845
Powered rongeur.
§882.4900
Skullplate screwdriver.
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Subpart F—NEUROLOGICAL THERAPEUTIC DEVICES

§882.5030
Methyl methacrylate for aneurysmorrhaphy.
§882.5050
Biofeedback device.
§882.5070
Bite block.
§882.5150
Intravascular occluding catheter.
§882.5175
Carotid artery clamp.
§882.5200
Aneurysm clip.
§882.5225
Implanted malleable clip.
§882.5235
Aversive conditioning device.
§882.5250
Burr hole cover.
§882.5275
Nerve cuff.
§882.5300
Methyl methacrylate for cranioplasty.
§882.5320
Preformed alterable cranioplasty plate.
§882.5330
Preformed nonalterable cranioplasty plate.
§882.5360
Cranioplasty plate fastener.
§882.5500
Lesion temperature monitor.
§882.5550
Central nervous system fluid shunt and components.
§882.5600
Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
§882.5700
Thermal system for insomnia.
§882.5800
Cranial electrotherapy stimulator.
§882.5801
Computerized behavioral therapy device for psychiatric disorders.
§882.5802
Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
§882.5805
Repetitive transcranial magnetic stimulation system.
§882.5808
Transcranial magnetic stimulator for headache.
§882.5810
External functional neuromuscular stimulator.
§882.5820
Implanted cerebellar stimulator.
§882.5830
Implanted diaphragmatic/phrenic nerve stimulator.
§882.5840
Implanted intracerebral/subcortical stimulator for pain relief.
§882.5850
Implanted spinal cord stimulator for bladder evacuation.
§882.5860
Implanted neuromuscular stimulator.
§882.5870
Implanted peripheral nerve stimulator for pain relief.
§882.5880
Implanted spinal cord stimulator for pain relief.
§882.5890
Transcutaneous electrical nerve stimulator for pain relief.
§882.5891
Transcutaneous electrical nerve stimulator to treat headache.
§882.5892
External vagal nerve stimulator for headache.
§882.5893
Thermal vestibular stimulator for headache.
§882.5894
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
§882.5895
Vibratory counter-stimulation device.
§882.5896
Percutaneous nerve stimulator for substance use disorders.
§882.5900
Preformed craniosynostosis strip.
§882.5897
External upper limb tremor stimulator.
§882.5910
Dura substitute.
§882.5940
Electroconvulsive therapy device.
§882.5950
Neurovascular embolization device.
§882.5960
Skull tongs for traction.
§882.5970
Cranial orthosis.
§882.5975
Human dura mater.

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