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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, Angiographic
510(k) Number K023441
Device Name PHILIPS MULTIDIAGNOST ELEVA
Applicant
PHILIPS MEDICAL SYSTEMS
4-6 VEENPLUIS, P.O. BOX 1000
BEST,  NL 5680 DA
Applicant Contact LYNN HARMER
Correspondent
UNDERWRITERS LABORATORIES, INC.
1655 SCOTT BLVD.
SANTA CLARA,  CA  95050
Correspondent Contact LYNN HARMER
Regulation Number892.1600
Classification Product Code
IZI  
Date Received10/15/2002
Decision Date 10/30/2002
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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