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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name transducer, ultrasonic, diagnostic
510(k) Number K081802
Device Name CX50 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy.
bothell,  WA  98021
Original Contact rob butler
Regulation Number892.1570
Classification Product Code
ITX  
Subsequent Product Codes
IYN   IYO  
Date Received06/26/2008
Decision Date 07/11/2008
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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