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FDA 510(k)

Puritan Bennett 980 Series Ventilator System

K-Number: K193056 · 2020-11-20

ApplicantCovidien, LLC
Decision Date2020-11-20
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Puritan Bennett 980 Series Ventilator System is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2020-11-20 under approval number K193056. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Puritan Bennett 980 Series Ventilator System?

Puritan Bennett 980 Series Ventilator System is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Covidien, LLC. The 510(k) number is K193056.

When was Puritan Bennett 980 Series Ventilator System approved by the FDA?

Puritan Bennett 980 Series Ventilator System received FDA 510(k) clearance on 2020-11-20, under approval number K193056.

What company makes Puritan Bennett 980 Series Ventilator System?

Puritan Bennett 980 Series Ventilator System is manufactured by Covidien, LLC.

What is the FDA product code for Puritan Bennett 980 Series Ventilator System?

The FDA product code for Puritan Bennett 980 Series Ventilator System is CBK.

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Related Devices (Code: CBK)

K153046HAMILTON-MR1Hamilton Medical AG K152068Astral 100/150Resmed, Ltd. K143035Flight 60 VentilatorFlight Medical Innovations , Ltd. K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP K162738Puritan Bennett 980 Ventilator SystemCovidien K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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