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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
Applicant
Philips Medical Systems North America, Inc.
22100 Bothell Everett Hwy
P.O. Box 3003
Bothell,  WA  98021 -8431
Applicant Contact LYNN HARMER
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
IZI  
Date Received01/24/2005
Decision Date 02/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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