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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 K130842
Device Name ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES
Applicant
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
VEENPLUIS 4-6
BEST,  NL 5684 PC
Applicant Contact JOS VAN VROONHOVEN
Correspondent
DEKRA CERTIFICATION B.V.
UTRECHTSEWEG 310
ARNHEM,  NL NL-6812 AR
Correspondent Contact J.A. VAN VUGT
Regulation Number892.1600
Classification Product Code
IZI  
Date Received03/27/2013
Decision Date 05/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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