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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 K923022
Device Name INSTRUMENTARIUM MEGA4 HT
Applicant
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207 -6025
Applicant Contact RICHARD E HALBCH
Correspondent
INSTRUMENTARIUM IMAGING, INC.
300 WEST EDGERTON AVE.
MILWAUKEE,  WI  53207 -6025
Correspondent Contact RICHARD E HALBCH
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/23/1992
Decision Date 09/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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