WELCH ALLYN OPHTHALMOSCOPE— 510(k) K950461

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K950461 for WELCH ALLYN OPHTHALMOSCOPE, Substantially Equivalent on 1995-04-04. Applicant: Welch Allyn, Inc.. Device class: 2.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1995-02-03
Decision date: 1995-04-04
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.