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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 K082173
Device Name Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S
Applicant
Cardiac Science Corporation
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Applicant Contact BEVERLY MAGRANE
Correspondent
Cardiac Science Corporation
3303 Monte Villa Pkwy.
Bothell,  WA  98021
Correspondent Contact BEVERLY MAGRANE
Regulation Number870.2340
Classification Product Code
DPS  
Date Received08/01/2008
Decision Date 08/26/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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