ZOLL E SERIES WITH SEE-THRU CPR

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 See-thru Cpr.

Pre-market Notification Details

Device IDK070455
510k NumberK070455
Device Name:ZOLL E SERIES WITH SEE-THRU CPR
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  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-02-16
Decision Date2007-04-26
Summary:summary

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