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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K931585
Device Name CORFAX CARDIAC DATA TRANSMITTER
Applicant
Ralin Medical, Inc.
8320 SW Nimbus Ave.
Bldg. 2
Beaverton,  OR  97005
Applicant Contact DONALD M OWEN
Correspondent
Ralin Medical, Inc.
8320 SW Nimbus Ave.
Bldg. 2
Beaverton,  OR  97005
Correspondent Contact DONALD M OWEN
Regulation Number870.2920
Classification Product Code
DXH  
Date Received03/31/1993
Decision Date 03/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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