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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name table, radiographic, tilting
510(k) Number K970640
Device Name PHILIPS EASY DIAGNOST
Original Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 bridgeport ave.
shelton,  CT  06484
Original Contact peter altman
Regulation Number892.1980
Classification Product Code
IXR  
Date Received02/20/1997
Decision Date 03/21/1997
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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