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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 K120703
Device Name ZONARE ZS3 DIAGNOSTIC UNLTRASOUND SYSTEM
Original Applicant
ZONARE MEDICAL SYSTEMS, INC.
420 north bernardo avenue
mountain view,  CA  94043
Original Contact mark job
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received03/08/2012
Decision Date 04/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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