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510(k) K193056 · CBK Ventilator, Continuous, Facility Use

Puritan Bennett 980 Series Ventilator System

Applicant	Covidien, LLC, Boulder CO, US
Decision	Substantially Equivalent, Nov 20, 2020
Received	Nov 1, 2019
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K193056

Date	Firm and product	Code	Linked 510(k)
Apr 25, 2022	Medtronic formerly Covidien Puritan Bennett 980 Series Ventilator Open, Classified	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980A1ENNISB Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980A3ENNISB Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980S1ENDICU Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980S3ENDICU Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980U1ENASAA Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980U1ESDIUC Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980U3ESDIUU Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator,980X1ENAIQC Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1ENDIPC Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1ENDIUU Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1ENNISB Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1JADIJJ Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980X1PLDIPC Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980X2ESDIEC Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980X3ENDIUU Terminated	CBK	None listed
Dec 9, 2021	Covidien Llc Puritan Bennett 980 Series Ventilator, 980X3JADIJJ Terminated	CBK	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.