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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K873836
Device Name MAMMOGRAPHIC KVP METER MODEL 232
Applicant
Radiation Measurements, Inc.
P.O. Box 327
7617 Donna Dr.
Middleton,  WI  53562
Applicant Contact JOEL R SCHENCK
Correspondent
Radiation Measurements, Inc.
P.O. Box 327
7617 Donna Dr.
Middleton,  WI  53562
Correspondent Contact JOEL R SCHENCK
Regulation Number892.1710
Classification Product Code
IZH  
Date Received09/21/1987
Decision Date 10/16/1987
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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