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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tonometer, Ac-Powered
510(k) Number K863217
Device Name DIGILAB MODULAR ONE-APPLANATION TONOMETER
Applicant
BIO-RAD
180 Cabot Street
Beverly,  MA  01915
Applicant Contact DAVE P MACADAMS
Correspondent
BIO-RAD
180 Cabot Street
Beverly,  MA  01915
Correspondent Contact DAVE P MACADAMS
Regulation Number886.1930
Classification Product Code
HKX  
Date Received08/20/1986
Decision Date 09/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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