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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 K984545
Device Name RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST,  NL 5680
Applicant Contact P. ALTMAN
Correspondent
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST,  NL 5680
Correspondent Contact P. ALTMAN
Regulation Number892.1600
Classification Product Code
IZI  
Date Received12/22/1998
Decision Date 02/25/1999
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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