Cleared Traditional

K955043 - WELCH ALLYN BI-OTOSCOPE
(FDA 510(k) Clearance)

K955043 · Welch Allyn, Inc. · Ear, Nose, Throat device

Nov 1995

Decision

11d

Days

Class 1

Risk

K955043 is an FDA 510(k) clearance for the WELCH ALLYN BI-OTOSCOPE. 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 November 14, 1995, 11 days after receiving the submission on November 3, 1995.

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

Submission Details

510(k) Number	K955043 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 03, 1995
Decision Date	November 14, 1995
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF