AMICO DH-W35 OPHTHALMOSCOPE SERIES— 510(k) K131939

Name: FDA 510(k) clearance K131939
Creator: U.S. Food and Drug Administration
Published: 2014-03-26

Substantially Equivalent

Amico Diagnostic Incorporated

FDA 510(k) clearance K131939 for AMICO DH-W35 OPHTHALMOSCOPE SERIES, Substantially Equivalent on 2014-03-26. Applicant: Amico Diagnostic Incorporated. Device class: 2.

Clearance details

Applicant: Amico Diagnostic Incorporated
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2013-06-27
Decision date: 2014-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Apollo Beach, FL, US

Download summary PDF View on FDA.gov ↗

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