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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 K895328
Device Name MAGNETIC RESONANCE SYSTEM MODEL BMT-1100
Applicant
Bruker Medical Imaging, Inc.
5111 Academy Dr.
Lisle,  IL  60532
Applicant Contact KENNETH PASTOTNIK
Correspondent
Bruker Medical Imaging, Inc.
5111 Academy Dr.
Lisle,  IL  60532
Correspondent Contact KENNETH PASTOTNIK
Regulation Number892.1000
Classification Product Code
LNH  
Date Received08/31/1989
Decision Date 03/09/1990
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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