OPHTHALMOSCOPE, MODEL #11100— 510(k) K770768

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K770768 for OPHTHALMOSCOPE, MODEL #11100, Substantially Equivalent on 1977-05-06. 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: 1977-04-28
Decision date: 1977-05-06
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.