21 CFR 886.4610 — Applicator, Ocular Pressure

Ophthalmic (OP) · Part 886 Subpart E—Surgical Devices · § 886.4610

Identification

An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
LCCApplicator, Ocular Pressure263rd Party
Innolitics

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