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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Synchronizer, Ecg / Respirator, Radiographic
510(k) Number K854976
Device Name RMI RESPIRATORY GATING SYSTEM MODEL 301
Applicant
Radiation Measurements, Inc.
P.O. Box 327
7617 Donna Dr.
Middleton,  WI  53562
Applicant Contact MICHELE J WOLFF
Correspondent
Radiation Measurements, Inc.
P.O. Box 327
7617 Donna Dr.
Middleton,  WI  53562
Correspondent Contact MICHELE J WOLFF
Regulation Number892.1970
Classification Product Code
IXO  
Date Received12/12/1985
Decision Date 05/07/1986
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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