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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 K023130
Device Name ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM
Applicant
Mri Devices Corp.
1515 Paramount Dr.
Waukesha,  WI  53186
Applicant Contact WILLIAM J DINEHART
Correspondent
Mri Devices Corp.
1515 Paramount Dr.
Waukesha,  WI  53186
Correspondent Contact WILLIAM J DINEHART
Regulation Number892.1000
Classification Product Code
LNH  
Date Received09/20/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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