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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 K994351
Device Name M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM
Applicant
RESONANCE TECHNOLOGY, INC.
18121 PARTHENIA ST.
NORTHRIDGE,  CA  91325
Applicant Contact MOKHTAR ZIARATI
Correspondent
RESONANCE TECHNOLOGY, INC.
18121 PARTHENIA ST.
NORTHRIDGE,  CA  91325
Correspondent Contact MOKHTAR ZIARATI
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/23/1999
Decision Date 03/22/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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