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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K860061
Device Name OCULAB BIOMETRICPEN
Applicant
Oculab, Inc.
443 W. Colorado St.
Glendale,  CA  91205
Applicant Contact WALLACE, M.D.
Correspondent
Oculab, Inc.
443 W. Colorado St.
Glendale,  CA  91205
Correspondent Contact WALLACE, M.D.
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/06/1986
Decision Date 03/10/1986
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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