ZOLL E SERIES WITH CPRREADYCHARGE

Automated External Defibrillators (non-wearable)

ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS

The following data is part of a premarket notification filed by Zoll Medical Corporation, World Wide Headquarters with the FDA for Zoll E Series With Cprreadycharge.

Pre-market Notification Details

Device IDK091265
510k NumberK091265
Device Name:ZOLL E SERIES WITH CPRREADYCHARGE
ClassificationAutomated External Defibrillators (non-wearable)
Applicant ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford,  MA  01824 -4105
ContactEileen M Boyle
CorrespondentEileen M Boyle
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford,  MA  01824 -4105
Product CodeMKJ  
Subsequent Product CodeDPS
Subsequent Product CodeLIX
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-30
Decision Date2009-12-23
Summary:summary

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