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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Ultrasonic, Diagnostic
510(k) Number K923348
Device Name OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED
Applicant
Zeiss Humphrey System
2992 Alvarado St.
P.O. Box 5400
San Leandro,  CA  94577
Applicant Contact BERRY DODD
Correspondent
Zeiss Humphrey System
2992 Alvarado St.
P.O. Box 5400
San Leandro,  CA  94577
Correspondent Contact BERRY DODD
Regulation Number892.1570
Classification Product Code
ITX  
Date Received05/28/1992
Decision Date 12/10/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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