ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE

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 Aedpro With 2010 Aha Guidelines Software Update.

Pre-market Notification Details

Device IDK110526
510k NumberK110526
Device Name:ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
ClassificationAutomated External Defibrillators (non-wearable)
Applicant ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford,  MA  01824 -4105
ContactEileen M Boyle
CorrespondentEileen M Boyle
ZOLL MEDICAL CORPORATION 269 MILL ROAD Chelmsford,  MA  01824 -4105
Product CodeMKJ  
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-02-24
Decision Date2011-03-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847946099329 K110526 000
00847946016838 K110526 000
00847946016821 K110526 000
00847946016166 K110526 000
00847946016159 K110526 000
00847946016142 K110526 000
00847946016135 K110526 000
00847946016128 K110526 000

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