Cleared Traditional

KEELER SPECTRA INDIRECT OPHTHALMOSCOPE

K970029 · Keeler Instruments, Inc. · Ophthalmic
Apr 1997
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K970029 is an FDA 510(k) clearance for the KEELER SPECTRA INDIRECT OPHTHALMOSCOPE, a Ophthalmoscope, Battery-powered (Class II — Special Controls, product code HLJ), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on April 2, 1997, 89 days after receiving the submission on January 3, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K970029 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1997
Decision Date April 02, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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

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