Cleared Traditional

WELCH ALLYN VIDEO EPISCOPE

K952835 · Welch Allyn, Inc. · General Hospital
Sep 1995
Decision
94d
Days
Class 1
Risk

About This 510(k) Submission

K952835 is an FDA 510(k) clearance for the WELCH ALLYN VIDEO EPISCOPE, a Device, Medical Examination, Ac Powered (Class I — General Controls, product code KZF), submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on September 22, 1995, 94 days after receiving the submission on June 20, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6320.

Submission Details

510(k) Number K952835 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1995
Decision Date September 22, 1995
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KZF — Device, Medical Examination, Ac Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6320

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