Cleared Traditional

KEELER PULSAIR 3000 NON CONTACT TONOMETER

K990257 · Keeler Instruments, Inc. · Ophthalmic
Mar 1999
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K990257 is an FDA 510(k) clearance for the KEELER PULSAIR 3000 NON CONTACT TONOMETER, 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 March 25, 1999, 57 days after receiving the submission on January 27, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K990257 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 1999
Decision Date March 25, 1999
Days to Decision 57 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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

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