Cleared Traditional

ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE

K854751 · Aspen Laboratories, Inc. · Ear, Nose, Throat
Feb 1986
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K854751 is an FDA 510(k) clearance for the ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE, a Source, Carrier, Fiberoptic Light (Class I — General Controls, product code EQH), submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on February 28, 1986, 94 days after receiving the submission on November 26, 1985. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4350.

Submission Details

510(k) Number K854751 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1985
Decision Date February 28, 1986
Days to Decision 94 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

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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