21 C.F.R. PART 882--NEUROLOGICAL DEVICES


TITLE 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.
�882.1460
Nystagmograph.
�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.
�882.1570
Powered direct-contact temperature measurement device.
�882.1610
Alpha monitor.
�882.1620
Intracranial pressure monitoring 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.
�882.1950
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.
�882.5800
Cranial electrotheraphy stimulator.
�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.
�882.5900
Preformed craniosynostosis strip.
�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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