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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 K141369
Device Name VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM
Original Applicant
PHILIPS ULTRASOUND, INC.
22100 bothell everett hwy.
bothell,  WA  98021
Original Contact saraswathi deora
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received05/23/2014
Decision Date 07/02/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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