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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 K943956
Device Name RETINA TOMOGRAPH AND FLOWMETER
Applicant
Heidelberg Engineering
Optische Meb Systeme Gmbh
Im Neuenheimer Feld 519
D06900 Heidelberg,Germany,  DE
Applicant Contact GERHARD ZINSER
Correspondent
Heidelberg Engineering
Optische Meb Systeme Gmbh
Im Neuenheimer Feld 519
D06900 Heidelberg,Germany,  DE
Correspondent Contact GERHARD ZINSER
Regulation Number886.1570
Classification Product Code
HLI  
Date Received08/15/1994
Decision Date 11/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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