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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 K921443
Device Name TIP & MEMBRANE ASSEMBLY
Applicant
Bio-Rad
635 W. Colorado St.
Glendale,  CA  91204
Applicant Contact RICHARD W TEASDALE
Correspondent
Bio-Rad
635 W. Colorado St.
Glendale,  CA  91204
Correspondent Contact RICHARD W TEASDALE
Regulation Number886.1930
Classification Product Code
HKX  
Date Received02/25/1992
Decision Date 06/22/1993
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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