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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 K130499
Device Name IU22 DIAGNOSTIC ULTRASOUND SYSTEM
Applicant
PHILIPS ULTRASOUND, INC.
22100 BOTHELL EVERETT HWY.
BOTHELL,  WA  98021 -8431
Applicant Contact JESSICA STENBERG
Correspondent
PHILIPS ULTRASOUND, INC.
22100 BOTHELL EVERETT HWY.
BOTHELL,  WA  98021 -8431
Correspondent Contact JESSICA STENBERG
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received02/26/2013
Decision Date 06/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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