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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 K001634
Device Name CARDIOSENTRY EVENT MONITOR, MODEL 8470-01
Applicant
TZ MEDICAL, INC.
15858 S.W. UPPER BOONES FERRY
RD.
LAKE OSWEGO,  OR  97035
Applicant Contact BYRON ZAHLER
Correspondent
TZ MEDICAL, INC.
15858 S.W. UPPER BOONES FERRY
RD.
LAKE OSWEGO,  OR  97035
Correspondent Contact BYRON ZAHLER
Regulation Number870.2920
Classification Product Code
DXH  
Date Received05/26/2000
Decision Date 12/21/2000
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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