ZOLL X Series

Automated External Defibrillators (non-wearable)

ZOLL MEDICAL CORPORATION

The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for Zoll X Series.

Pre-market Notification Details

Device IDK142915
510k NumberK142915
Device Name:ZOLL X Series
ClassificationAutomated External Defibrillators (non-wearable)
Applicant ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford,  MA  01824 -4105
ContactTammay Shukla
CorrespondentTammay Shukla
ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford,  MA  01824 -4105
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-07
Decision Date2014-12-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00847946021610 K142915 000
00847946019976 K142915 000

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