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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, x-ray, stationary
510(k) Number K050151
Device Name MULTIDIAGNOST ELEVA
Original Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
22100 bothell everett hwy
p.o. box 3003
bothell,  WA  98021 8431
Original Contact lynn harmer
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
IZI  
Date Received01/24/2005
Decision Date 02/09/2005
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
Recalls CDRH Recalls
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