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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2020-11-20 under 510(k) 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. The listed applicant is Covidien, LLC. The 510(k) number is K193056.

When did Puritan Bennett 980 Series Ventilator System receive FDA 510(k) clearance?

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

Who is the listed applicant for Puritan Bennett 980 Series Ventilator System?

The FDA 510(k) record lists Covidien, LLC as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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