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CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2009]
[CITE: 21CFR886.1940]
 See Related Information on 886.1940 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 886 -- OPHTHALMIC DEVICES

Subpart B--Diagnostic Devices

Sec. 886.1940 Tonometer sterilizer.

(a)Identification. A tonometer sterilizer is an AC-powered device intended to heat sterilize a tonometer (a device used to measure intraocular pressure).

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 886.9.

[55 FR 48443, Nov. 20, 1990, as amended at 65 FR 2321, Jan. 14, 2000]

 
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