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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 K883650
Device Name INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110
Original Applicant
INSTRUMENTARIUM CORP.
c/o biometric research institu
1401 wilson blvd., suite 400
arlington,  VA  22209
Original Contact frank l hurley
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/29/1988
Decision Date 09/16/1988
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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