Cleared Traditional

VISTA FINOFF TRANSILLUMINATOR (AC-POWERED)

K893170 · Keeler Instruments, Inc. · Ophthalmic
Jun 1989
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K893170 is an FDA 510(k) clearance for the VISTA FINOFF TRANSILLUMINATOR (AC-POWERED), a Transilluminator, Ac-powered (Class II — Special Controls, product code HJM), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on June 5, 1989, 41 days after receiving the submission on April 25, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1945.

Submission Details

510(k) Number K893170 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1989
Decision Date June 05, 1989
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HJM — Transilluminator, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1945

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