Cleared Traditional

K943916 - VIDEOTOSCOPE (FDA 510(k) Clearance)

K943916 · Welch Allyn, Inc. · Ear, Nose, Throat device

Aug 1994

Decision

14d

Days

Class 1

Risk

K943916 is an FDA 510(k) clearance for the VIDEOTOSCOPE. This device is classified as a Otoscope (Class I - General Controls, product code ERA).

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on August 25, 1994, 14 days after receiving the submission on August 11, 1994.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.

Submission Details

510(k) Number	K943916 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 11, 1994
Decision Date	August 25, 1994
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ERA — Otoscope
Device Class	Class I - General Controls
CFR Regulation	21 CFR 874.4770