ZOLL E SERIES

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.

Pre-market Notification Details

Device IDK133239
510k NumberK133239
Device Name:ZOLL E SERIES
ClassificationAutomated External Defibrillators (non-wearable)
Applicant ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford,  MA  01824 -4105
ContactTanmay B Shukla
CorrespondentTanmay B Shukla
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford,  MA  01824 -4105
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-21
Decision Date2015-01-16
Summary:summary

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