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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 K150564
Device Name Spaulding Electrocardiograph 2100iQ
Applicant
Spaulding Clinical Research, LLC
525 S.Silverbrook Drive
West Bend,  WI  53095
Applicant Contact Andre Leak
Correspondent
Spaulding Clinical Research, LLC
525 S.Silverbrook Drive
West Bend,  WI  53095
Correspondent Contact Andre Leak
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/06/2015
Decision Date 08/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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