ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE

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 With 2010 Aha Guidelines Software Update.

Pre-market Notification Details

Device IDK110361
510k NumberK110361
Device Name:ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
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 Received2011-02-07
Decision Date2011-03-08
Summary:summary

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