Cleared Traditional

AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS

K851264 · American Medical Optics · Ophthalmic
May 1985
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K851264 is an FDA 510(k) clearance for the AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS, a Ophthalmoscope, Ac-powered (Class II — Special Controls, product code HLI), submitted by American Medical Optics (Irvine, US). The FDA issued a Cleared decision on May 1, 1985, 34 days after receiving the submission on March 28, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K851264 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 1985
Decision Date May 01, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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