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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 K093563
Model IU22
Device Name IU22 ULTRASOUND SYSTEM AND TRANSDUCERS
Original Applicant
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy.
bothell,  WA  98021
Original Contact nancy burke
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/18/2009
Decision Date 02/01/2010
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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