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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K914725
Device Name COORDINATOR, CABLE INPUT
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 Number870.2340
Classification Product Code
DPS  
Date Received10/21/1991
Decision Date 11/05/1991
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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