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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 K030455
Device Name BORIS PLATFORM DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy.
p.o. box 3003
bothell,  WA  98041
Original Contact lynn harmer
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/11/2003
Decision Date 03/13/2003
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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