Cleared Traditional

K952578 - WELCH ALLY OTOSCOPE
(FDA 510(k) Clearance)

K952578 · Welch Allyn, Inc. · Ear, Nose, Throat device

Jul 1995

Decision

35d

Days

Class 1

Risk

K952578 is an FDA 510(k) clearance for the WELCH ALLY 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 July 10, 1995, 35 days after receiving the submission on June 5, 1995.

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

Submission Details

510(k) Number	K952578 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 05, 1995
Decision Date	July 10, 1995
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF