Puritan Bennett Cuff Pressure Manager

Cuff, Tracheal Tube, Inflatable

Covidien Llc

The following data is part of a premarket notification filed by Covidien Llc with the FDA for Puritan Bennett Cuff Pressure Manager.

Pre-market Notification Details

Device IDK202874
510k NumberK202874
Device Name:Puritan Bennett Cuff Pressure Manager
ClassificationCuff, Tracheal Tube, Inflatable
Applicant Covidien Llc 6F, Building 3, 2388 Chenhang Road Shanghai,  CN 201114
ContactJenny Liu
CorrespondentJenny Liu
Covidien Llc 6F, Building 3, 2388 Chenhang Road Shanghai,  CN 201114
Product CodeBSK  
CFR Regulation Number868.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2021-01-09

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