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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K131939
Device Name AMICO DH-W35 OPHTHALMOSCOPE SERIES
Applicant
Amico Diagnostic Incorporated
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Applicant Contact LAUREN CHRAPOWITZKY
Correspondent
Amico Diagnostic Incorporated
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact LAUREN CHRAPOWITZKY
Regulation Number886.1570
Classification Product Code
HLI  
Date Received06/27/2013
Decision Date 03/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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