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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 K883649
Device Name INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H
Original Applicant
INSTRUMENTARIUM CORP.
1120 g. street, n.w.
washington,  DC  20005
Original Contact robert a dormer
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/29/1988
Decision Date 10/19/1988
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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