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 IDK141774
510k NumberK141774
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  
Subsequent Product CodeCCK
Subsequent Product CodeDQA
Subsequent Product CodeDRO
Subsequent Product CodeDRT
Subsequent Product CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeLDD
Subsequent Product CodeLIX
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-07-02
Decision Date2014-11-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.