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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 K121983
Models C52, L115, P42, UP600
Device Name DIAGNOSTIC DOPPLER ULTRASOUND SYSTEM CURVED LINEAR ARRAY 2-5 MHZ TRANSDUCER LINEAR ARRAY 5-11 MHZ TRANSDUCER PHASE ARRA
Original Applicant
BENQ MEDICAL TECHNOLOGY CORPATION
7263 cronin circle
dublin,  CA  94568
Original Contact bob leiker
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received07/06/2012
Decision Date 09/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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