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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 K142953
Device Name OCT-Camera
Applicant
Optomedical Technologies GmbH
Maria-Goeppert-Strasse 1
Luebeck,  DE 23562
Applicant Contact Alexander Holzhey
Correspondent
Emergo Group
Prinsessegracht 20
The Hague,  NL
Correspondent Contact Dirk Meier
Regulation Number886.1570
Classification Product Code
HLI  
Subsequent Product Code
OBO  
Date Received10/10/2014
Decision Date 03/04/2015
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
Recalls CDRH Recalls
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