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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 K981190
Device Name HIGH IMPEDANCE CARDIAC GATING CABLE
Applicant
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE,  WI  53188
Applicant Contact LARRY KROGER
Correspondent
GE MEDICAL SYSTEMS
P.O. BOX 414
MILWAUKEE,  WI  53188
Correspondent Contact LARRY KROGER
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/02/1998
Decision Date 06/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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