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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 K110065
Device Name SPAULDING IQ ELECTROCARDIOGRAPH
Applicant
Spaulding Clinical Research, LLC
525 S.Silverbrook Dr.
West Bend,  WI  53095
Applicant Contact PAUL SCHULTZ
Correspondent
Spaulding Clinical Research, LLC
525 S.Silverbrook Dr.
West Bend,  WI  53095
Correspondent Contact PAUL SCHULTZ
Regulation Number870.2340
Classification Product Code
DPS  
Date Received01/10/2011
Decision Date 03/02/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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