(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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