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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 K912581
Device Name ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
Applicant
Carl Zeiss, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Applicant Contact CHRISTOPHER TALBOT
Correspondent
Carl Zeiss, Inc.
305 College Rd. E.
Princeton,  NJ  08540
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number886.1570
Classification Product Code
HLI  
Date Received06/12/1991
Decision Date 12/23/1991
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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