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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pacemaker, cardiac, external transcutaneous (non-invasive)
510(k) Number K983196
Device Name PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
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 Number870.5550
Classification Product Code
DRO  
Date Received09/11/1998
Decision Date 09/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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