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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K051618
Device Name SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64
Applicant
Midwest Rf, LLC
535 Norton Dr.
P.O. Box 348
Hartland,  WI  53029
Applicant Contact DAVID M PETERSON
Correspondent
Midwest Rf, LLC
535 Norton Dr.
P.O. Box 348
Hartland,  WI  53029
Correspondent Contact DAVID M PETERSON
Regulation Number892.1000
Classification Product Code
MOS  
Date Received06/17/2005
Decision Date 08/02/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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