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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrocardiograph
510(k) Number K101576
Device Name CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES
Applicant
Team Innovations, Inc.
2521 S. 98 St.
West Allis,  WI  53227
Applicant Contact MARK TIEGS
Correspondent
Team Innovations, Inc.
2521 S. 98 St.
West Allis,  WI  53227
Correspondent Contact MARK TIEGS
Regulation Number870.2360
Classification Product Code
DRX  
Date Received06/07/2010
Decision Date 07/22/2010
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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