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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 K904966
Device Name DATAMED MODEL 401A TRANSRECIEVER
Applicant
Datamed, Inc.
1519 S. Lewis
Tulsa,  OK  74104
Applicant Contact HUGH HOLLY
Correspondent
Datamed, Inc.
1519 S. Lewis
Tulsa,  OK  74104
Correspondent Contact HUGH HOLLY
Regulation Number870.2920
Classification Product Code
DXH  
Date Received11/05/1990
Decision Date 07/18/1991
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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