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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 K883523
Device Name TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE, W/PULSE
Applicant
CARDIOTRONICS, INC.
2726 LOKER AVE.
WEST CARLSBAD,  CA  92008
Applicant Contact TIM J WAY
Correspondent
CARDIOTRONICS, INC.
2726 LOKER AVE.
WEST CARLSBAD,  CA  92008
Correspondent Contact TIM J WAY
Regulation Number870.5550
Classification Product Code
DRO  
Date Received08/17/1988
Decision Date 10/06/1988
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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