Cleared Traditional

KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION

K911721 · Keeler Instruments, Inc. · Ophthalmic
Jun 1991
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K911721 is an FDA 510(k) clearance for the KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION, a Tonometer, Ac-powered (Class II — Special Controls, product code HKX), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on June 25, 1991, 69 days after receiving the submission on April 17, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K911721 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1991
Decision Date June 25, 1991
Days to Decision 69 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HKX — Tonometer, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930

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