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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Block, Test, Ultrasonic Scanner Calibration
510(k) Number K893216
Device Name RMI ULTRASOUND DOPPLER PHANTOM SYSTEM
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 Number882.1925
Classification Product Code
GXX  
Date Received04/27/1989
Decision Date 09/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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