Cleared Traditional

GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT

K941660 · Gm Engineering, Inc. · Ophthalmic

May 1994

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K941660 is an FDA 510(k) clearance for the GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT, a Endoscope, Ophthalmic (Class II — Special Controls, product code KYH), submitted by Gm Engineering, Inc. (La Verne, US). The FDA issued a Cleared decision on May 24, 1994, 49 days after receiving the submission on April 5, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K941660 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 1994
Decision Date	May 24, 1994
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement