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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 K043535
Device Name HD11 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
PHILIPS ULTRASOUND, INC.
3000 minuteman rd.
andover,  MA  01810
Original Contact steve singlar
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/22/2004
Decision Date 01/06/2005
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
Recalls CDRH Recalls
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