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FDA 510(k)

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger

K-Number: K211286 · 2021-11-16

ApplicantPall Corporation
Decision Date2021-11-16
Product CodeCAH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger is a medical device manufactured by Pall Corporation. It received FDA 510(k) clearance on 2021-11-16 under approval number K211286. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger?

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger is a medical device that received FDA 510(k) clearance on 2021-11-16. It is manufactured by Pall Corporation. The 510(k) number is K211286.

When was Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger approved by the FDA?

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger received FDA 510(k) clearance on 2021-11-16, under approval number K211286.

What company makes Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger?

Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger is manufactured by Pall Corporation.

What is the FDA product code for Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger?

The FDA product code for Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger is CAH.

Related Clinical Trials

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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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