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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K001796
Device Name GYROSCAN INTERA (R7.5)
Original Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
710 bridgeport ave.
shelton,  CT  06484
Original Contact peter altman
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/14/2000
Decision Date 09/06/2000
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
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