Cleared Traditional

GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT

K941662 · Gm Engineering, Inc. · Ear, Nose, Throat
Jul 1994
Decision
106d
Days
Class 1
Risk

About This 510(k) Submission

K941662 is an FDA 510(k) clearance for the GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by Gm Engineering, Inc. (La Verne, US). The FDA issued a Cleared decision on July 20, 1994, 106 days after receiving the submission on April 5, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K941662 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 1994
Decision Date July 20, 1994
Days to Decision 106 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EQH — Source, Carrier, Fiberoptic Light
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4350

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