ZOLL PROPAQ MD

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 Propaq Md.

Pre-market Notification Details

Device IDK112761
510k NumberK112761
Device Name:ZOLL PROPAQ MD
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 CodeDSK
Subsequent Product CodeDXN
Subsequent Product CodeLDD
Subsequent Product CodeLIX
CFR Regulation Number870.5310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-22
Decision Date2012-04-25
Summary:summary

NIH GUDID Devices

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00847946026639 K112761 000

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