21 C.F.R. § 886.1940 Tonometer sterilizer.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices
§ 886.1940 Tonometer sterilizer.