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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 K883622
Device Name INSTRUMENTARIUM ULF MR IMAGING SYSTEM
Applicant
Instrumentarium Corp.
C/O Biometric Research Institu
1401 Wilson Blvd., Suite 400
Arlington,  VA  22209
Applicant Contact FRANK L HURLEY
Correspondent
Instrumentarium Corp.
C/O Biometric Research Institu
1401 Wilson Blvd., Suite 400
Arlington,  VA  22209
Correspondent Contact FRANK L HURLEY
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/25/1988
Decision Date 09/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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