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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 K150055
Device Name OneStep Pediatric CPR Multi-Function Electrode
Applicant
Bio-Detek, Inc.
525 Narragansett Park Dr.
Pawtucket,  RI  02861
Applicant Contact CHUCK KOLIFRATH
Correspondent
ZOLL Medical Corporation
269 Mill Rd.
Chelsmford,  MA  01824
Correspondent Contact TANMAY SHUKLA
Regulation Number870.5310
Classification Product Code
MKJ  
Subsequent Product Code
LIX  
Date Received01/12/2015
Decision Date 05/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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