Puritan Bennett 840 Series Ventilator System

Ventilator, Continuous, Facility Use

Covidien LP

The following data is part of a premarket notification filed by Covidien Lp with the FDA for Puritan Bennett 840 Series Ventilator System.

Pre-market Notification Details

Device IDK151252
510k NumberK151252
Device Name:Puritan Bennett 840 Series Ventilator System
ClassificationVentilator, Continuous, Facility Use
Applicant Covidien LP 6135 Gunbarrel Ave Boulder,  CO  80301
ContactKelsey Lee
CorrespondentKelsey Lee
Covidien LP 6135 Gunbarrel Ave Boulder,  CO  80301
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-12
Decision Date2016-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884521254609 K151252 000
10884521658318 K151252 000
10884521658301 K151252 000
10884521658295 K151252 000
10884521658288 K151252 000
10884521101258 K151252 000
10884521101241 K151252 000

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