ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO

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 Aedpro With See-thru Cpr, Model Aedpro.

Pre-market Notification Details

Device IDK071025
510k NumberK071025
Device Name:ZOLL AEDPRO WITH SEE-THRU CPR, MODEL AEDPRO
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 Received2007-04-11
Decision Date2007-06-22
Summary:summary

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