ZOLL R 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 R Series.

Pre-market Notification Details

Device IDK120907
510k NumberK120907
Device Name:ZOLL R SERIES
ClassificationAutomated External Defibrillators (non-wearable)
Applicant ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford,  MA  01824 -4105
ContactCharles W Kolifrath
CorrespondentCharles W Kolifrath
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS 269 MILL ROAD Chelmsford,  MA  01824 -4105
Product CodeMKJ  
Subsequent Product CodeCCK
Subsequent Product CodeDQA
Subsequent Product CodeDRO
Subsequent Product CodeDRT
Subsequent Product CodeDXN
Subsequent Product CodeLDD
Subsequent Product CodeLIX
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-03-26
Decision Date2012-09-25
Summary:summary

NIH GUDID Devices

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