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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 K973267
Device Name TTM5000 TELEPHONIC EKG MONITOR
Applicant
Hds Medical, Inc.
2 Faire Winds
Languna Niguel,  CA  92677
Applicant Contact SEMIH CIRIT
Correspondent
Hds Medical, Inc.
2 Faire Winds
Languna Niguel,  CA  92677
Correspondent Contact SEMIH CIRIT
Regulation Number870.2920
Classification Product Code
DXH  
Date Received08/29/1997
Decision Date 01/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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