Code of Federal Regulations · Section

§ 886.1940 — Tonometer Sterilizer

21 C.F.R. § 886.1940

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(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.

Authorizing Statute