Cleared Traditional

RGB CAMERA SYSTEM

K872661 · Aspen Laboratories, Inc. · General & Plastic Surgery
Jul 1987
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K872661 is an FDA 510(k) clearance for the RGB CAMERA SYSTEM, a Camera, Television, Endoscopic, Without Audio (Class I — General Controls, product code FWF), submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on July 21, 1987, 14 days after receiving the submission on July 7, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4160.

Submission Details

510(k) Number K872661 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1987
Decision Date July 21, 1987
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FWF — Camera, Television, Endoscopic, Without Audio
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4160

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