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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K113176
Device Name MYSENSE HEART
Applicant
Cardiac Science Corporation
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact NEIL SHELLER
Correspondent
Cardiac Science Corporation
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact NEIL SHELLER
Regulation Number870.2800
Classification Product Code
DSH  
Date Received10/28/2011
Decision Date 12/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01382953
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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