Cleared Traditional

KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004

K032087 · Keeler Instruments, Inc. · Ophthalmic
Nov 2003
Decision
142d
Days
Class 2
Risk

About This 510(k) Submission

K032087 is an FDA 510(k) clearance for the KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004, 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 November 26, 2003, 142 days after receiving the submission on July 7, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K032087 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2003
Decision Date November 26, 2003
Days to Decision 142 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

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

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