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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 K041949
Device Name ALLURA XPER FD10
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
VEENPLUIS 4-6-
5684 PC BEST
THE NETHERLANDS,  NL
Applicant Contact LYNN HARMER
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
VEENPLUIS 4-6-
5684 PC BEST
THE NETHERLANDS,  NL
Correspondent Contact LYNN HARMER
Regulation Number892.1600
Classification Product Code
IZI  
Date Received07/20/2004
Decision Date 07/30/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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