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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 Doppler, Ultrasonic
510(k) Number K103471
Device Name UBM PLUS
Applicant
Accutome, Inc.
3222 Phoenixville Pike
Malvern,  PA  19355
Applicant Contact BRIAN T.S. BARRETT
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact BHAVESH V SHETH
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Code
ITX  
Date Received11/24/2010
Decision Date 03/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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