WELCH ALLYN OTOSCOPE— 510(k) K950787

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K950787 for WELCH ALLYN OTOSCOPE, Substantially Equivalent on 1995-04-06. Applicant: Welch Allyn, Inc.. Device class: 1.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code ERA
Device class: Class 1
Regulation: 21 CFR 874.4770
Advisory panel: Ear, Nose, Throat
Date received: 1995-02-21
Decision date: 1995-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.