Cleared Traditional

KEELER ACU 22XT OPHTHALMIC CRYO UNIT

K874555 · Keeler Instruments, Inc. · Ophthalmic
Jan 1988
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K874555 is an FDA 510(k) clearance for the KEELER ACU 22XT OPHTHALMIC CRYO UNIT, a Unit, Cryophthalmic (Class II — Special Controls, product code HPS), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on January 29, 1988, 86 days after receiving the submission on November 4, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number K874555 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1987
Decision Date January 29, 1988
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPS — Unit, Cryophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4170