WELCH ALLYN 11800 OPTHALMOSCOPE— 510(k) K003376

Name: FDA 510(k) clearance K003376
Creator: U.S. Food and Drug Administration
Published: 2001-01-25

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K003376 for WELCH ALLYN 11800 OPTHALMOSCOPE, Substantially Equivalent on 2001-01-25. 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: 2000-10-30
Decision date: 2001-01-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

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