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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 K894714
Device Name 1989 SOFTWARE REVISION TO THE BMT-1100
Applicant
Bruker Medical Imaging, Inc.
5111 Academy Dr.
Lisle,  IL  60532
Applicant Contact R PASTOTNIK
Correspondent
Bruker Medical Imaging, Inc.
5111 Academy Dr.
Lisle,  IL  60532
Correspondent Contact R PASTOTNIK
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/24/1989
Decision Date 11/15/1989
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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