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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 K031535
Device Name PHILIPS EASYDIAGNOST ELEVA
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL,  WA  98021 -3003
Applicant Contact LYNN T HARMER
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL,  WA  98021 -3003
Correspondent Contact LYNN T HARMER
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Codes
IXL   IXR   JAA  
Date Received05/16/2003
Decision Date 06/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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