Cleared Traditional

MS-30 AUTOMATIC PERIMETER

K943234 · Marco Ophthalmic, Inc. · Ophthalmic
Jul 1994
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K943234 is an FDA 510(k) clearance for the MS-30 AUTOMATIC PERIMETER, a Perimeter, Automatic, Ac-powered (Class I — General Controls, product code HPT), submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on July 27, 1994, 21 days after receiving the submission on July 6, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1605.

Submission Details

510(k) Number K943234 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 1994
Decision Date July 27, 1994
Days to Decision 21 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HPT — Perimeter, Automatic, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.1605

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