731 Series Ventilators

Ventilator, Continuous, Facility Use

ZOLL MEDICAL CORPORATION

The following data is part of a premarket notification filed by Zoll Medical Corporation with the FDA for 731 Series Ventilators.

Pre-market Notification Details

Device IDK162832
510k NumberK162832
Device Name:731 Series Ventilators
ClassificationVentilator, Continuous, Facility Use
Applicant ZOLL MEDICAL CORPORATION 269 & 271 MILL ROAD Chelmsford,  MA  01824 -4105
ContactChuck Kolifrath
CorrespondentChuck Kolifrath
ZOLL MEDICAL CORPORATION 269 & 271 MILL ROAD Chelmsford,  MA  01824 -4105
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-11
Decision Date2017-08-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847946024130 K162832 000
00847946023904 K162832 000
00847946023898 K162832 000
00847946023843 K162832 000
00847946023836 K162832 000
00847946023829 K162832 000

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