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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 K964888
Device Name HEART AIDE MULTPLE/HEART AIDE PLUS/HEART AIDE PLUS II
Applicant
Tz Medical, Inc.
15858 SW Upper Boones Ferry Rd.
Lake Oswego,  OR  97035
Applicant Contact D. JADEEN HAILEY
Correspondent
Tz Medical, Inc.
15858 SW Upper Boones Ferry Rd.
Lake Oswego,  OR  97035
Correspondent Contact D. JADEEN HAILEY
Regulation Number870.2920
Classification Product Code
DXH  
Date Received12/06/1996
Decision Date 02/28/1997
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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