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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name automated external defibrillators (non-wearable)
510(k) Number K110742
Device Name ONESTEP ADULT MULTI-FUNCTION ELECTRODE
Applicant
ZOLL MEDICAL CORPORATION
525 NARRAGANSETT PARK DRIVE
PAWTUCKET,  RI  02861
Applicant Contact ROBERT MORSE
Correspondent
ZOLL MEDICAL CORPORATION
525 NARRAGANSETT PARK DRIVE
PAWTUCKET,  RI  02861
Correspondent Contact ROBERT MORSE
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
LIX  
Date Received03/17/2011
Decision Date 04/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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