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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 K941705
Device Name NERVE FIBER ANALYZER
Applicant
Carl Zeiss Meditec, Inc.
9550 Waples St.,Ste 105
San Diego,  CA  92121
Applicant Contact ANDREAS W DREHER
Correspondent
Carl Zeiss Meditec, Inc.
9550 Waples St.,Ste 105
San Diego,  CA  92121
Correspondent Contact ANDREAS W DREHER
Regulation Number886.1570
Classification Product Code
HLI  
Date Received04/06/1994
Decision Date 07/18/1994
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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