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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR882.1880]
See Related Information on Evoked response mechanical stimulator. in CDRH databases



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

Subpart B--Neurological Diagnostic Devices

Sec. 882.1880 Evoked response mechanical stimulator.

(a)Identification. An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.

(b)Classification. Class II (performance standards).

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