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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K982817
Device Name EWC: ECG CABLE AND LEADWIRE SYSTEMS
Applicant
Ewc
N26w23315 Paul Rd.
Pewaukee,  WI  53072
Applicant Contact TIMOTHY M DAVIS
Correspondent
Ewc
N26w23315 Paul Rd.
Pewaukee,  WI  53072
Correspondent Contact TIMOTHY M DAVIS
Regulation Number870.2900
Classification Product Code
DSA  
Date Received08/11/1998
Decision Date 09/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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