FDA 510(k)

Ultipor U55/U55N 呼吸回路过滤器及热量和湿度交换器

K号: K211286 · 2021-11-16

决定日期2021-11-16

产品代码CAH

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决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Pall Corporation. The 510(k) number is K211286.

When did Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger receive FDA 510(k) clearance?

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

Who is the listed applicant for Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger?

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

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.

官方来源

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Ultipor U55/U55N 呼吸回路过滤器及热量和湿度交换器

器械摘要

常见问题

相关临床试验

相关器械（代码：CAH）

官方来源