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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 K083377
Device Name ACCUPEN
Applicant
Accutome Ultrasound, Inc.
263 Great Valley Pkwy.
Malvern,  PA  19355
Applicant Contact BRIAN T.S. BARRETT
Correspondent
Accutome Ultrasound, Inc.
263 Great Valley Pkwy.
Malvern,  PA  19355
Correspondent Contact BRIAN T.S. BARRETT
Regulation Number886.1930
Classification Product Code
HKX  
Date Received11/14/2008
Decision Date 07/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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