Cleared Traditional

VOROSCOPE(TM)

K871735 · Australian Biomedical Corporation , Ltd. · Ophthalmic
Jun 1987
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K871735 is an FDA 510(k) clearance for the VOROSCOPE(TM), a Ophthalmoscope, Battery-powered (Class II — Special Controls, product code HLJ), submitted by Australian Biomedical Corporation , Ltd. (Australia, AU). The FDA issued a Cleared decision on June 3, 1987, 29 days after receiving the submission on May 5, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number K871735 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1987
Decision Date June 03, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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