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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 K885223
Device Name RMI SHORT DISTANCE ALIGNMENT DEVICE
Applicant
Radiation Measurements, Inc.
P.O. Box 327
7617 Donna Dr.
Middleton,  WI  53562
Applicant Contact MARIE JENNARO
Correspondent
Radiation Measurements, Inc.
P.O. Box 327
7617 Donna Dr.
Middleton,  WI  53562
Correspondent Contact MARIE JENNARO
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/20/1988
Decision Date 02/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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