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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 K945972
Device Name DIGITAL AVERAGING TONOMETER
Applicant
OPTI-MED ELECTRONICS
6915 EASTSIDE ROAD,
BUILDING 8, UNIT 2
ANDERSON,  CA  96007
Applicant Contact HARRY A BOUGE
Correspondent
OPTI-MED ELECTRONICS
6915 EASTSIDE ROAD,
BUILDING 8, UNIT 2
ANDERSON,  CA  96007
Correspondent Contact HARRY A BOUGE
Regulation Number886.1930
Classification Product Code
HKX  
Date Received12/08/1994
Decision Date 08/17/1995
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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