Cleared Traditional

KEELER VANTAGE INDIRECT OPHTHALMOSCOPE

K942104 · Keeler Instruments, Inc. · Ophthalmic
Aug 1994
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K942104 is an FDA 510(k) clearance for the KEELER VANTAGE INDIRECT OPHTHALMOSCOPE, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on August 4, 1994, 94 days after receiving the submission on May 2, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K942104 FDA.gov
FDA Decision Cleared SESE
Date Received May 02, 1994
Decision Date August 04, 1994
Days to Decision 94 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HLI — Ophthalmoscope, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1570

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