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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 K883178
Device Name TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE
Applicant
Cardiotronics, Inc.
2726 Loker Ave.
West Carlsbad,  CA  92008
Applicant Contact TIM WAY
Correspondent
Cardiotronics, Inc.
2726 Loker Ave.
West Carlsbad,  CA  92008
Correspondent Contact TIM WAY
Regulation Number870.5550
Classification Product Code
DRO  
Date Received07/27/1988
Decision Date 11/09/1988
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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