Cleared Traditional

MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS

K930442 · Marco Ophthalmic, Inc. · Ophthalmic
Aug 1993
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K930442 is an FDA 510(k) clearance for the MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Marco Ophthalmic, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 9, 1993, 195 days after receiving the submission on January 26, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number K930442 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1993
Decision Date August 09, 1993
Days to Decision 195 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HKI — Camera, Ophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1120