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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 K152899
Device Name Philips Lumify Diagnostic Ultrasound System
Applicant
PHILIPS HEALTHCARE, INC.
22100 bothell everett highway
bothell,  WA  98021 -8431
Applicant Contact penny greco
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1394 25th street, nw
buffalo,  MN  55313
Correspodent Contact mark job
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received10/01/2015
Decision Date 10/30/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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