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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Aug 30, 2024.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[CITE: 21CFR870.2675]
See Related Information on Oscillometer. 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 870 -- CARDIOVASCULAR DEVICES

Subpart C - Cardiovascular Monitoring Devices

Sec. 870.2675 Oscillometer.

(a) Identification. An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries.

(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

[45 FR 7907, Feb. 5, 1980, as amended at 84 FR 71812, Dec. 30, 2019]

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