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FDA 510(k)

Puritan Bennett 980 Ventilator System

K-Number: K162738 · 2017-10-27

ApplicantCovidien
Decision Date2017-10-27
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Puritan Bennett 980 Ventilator System is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2017-10-27 under approval number K162738. 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 Ventilator System?

Puritan Bennett 980 Ventilator System is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Covidien. The 510(k) number is K162738.

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

Puritan Bennett 980 Ventilator System received FDA 510(k) clearance on 2017-10-27, under approval number K162738.

What company makes Puritan Bennett 980 Ventilator System?

Puritan Bennett 980 Ventilator System is manufactured by Covidien.

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

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

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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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