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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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