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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 K990106
Device Name ZOLL FIRST RESPONDER PADZ ADULT DEFIBRILLATION ELECTRODES
Applicant
Bio-Detek, Inc.
525 Narragansett Park Dr.
Pawtucket,  RI  02861
Applicant Contact MICHAEL R DUPELLE
Correspondent
Bio-Detek, Inc.
525 Narragansett Park Dr.
Pawtucket,  RI  02861
Correspondent Contact MICHAEL R DUPELLE
Regulation Number870.5310
Classification Product Code
MKJ  
Date Received01/12/1999
Decision Date 02/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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