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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 K983069
Device Name PHILIPS DUO DIAGNOST
Original Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 bridgeport ave.
shelton,  CT  06484
Original Contact peter altman
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Code
JAA  
Date Received09/02/1998
Decision Date 11/02/1998
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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