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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K002016
Device Name PHILIPS INTEGRIS ALLURA
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST,  NL 5680
Applicant Contact PETER ALTMAN
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST,  NL 5680
Correspondent Contact PETER ALTMAN
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received07/03/2000
Decision Date 09/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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