FDA 510(k)

Paragon Adult Maxi PMP Oxygenator with Tubing Pack

Número K: K201642 · 2020-09-18

Data da decisão2020-09-18

Código do produtoDTZ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Paragon Adult Maxi PMP Oxygenator with Tubing Pack is the device name listed in this FDA 510(k) record. The listed applicant is Chalice Medical , Ltd.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K201642. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Paragon Adult Maxi PMP Oxygenator with Tubing Pack?

Paragon Adult Maxi PMP Oxygenator with Tubing Pack is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is Chalice Medical , Ltd.. The 510(k) number is K201642.

When did Paragon Adult Maxi PMP Oxygenator with Tubing Pack receive FDA 510(k) clearance?

Paragon Adult Maxi PMP Oxygenator with Tubing Pack received FDA 510(k) clearance on 2020-09-18, under 510(k) number K201642.

Who is the listed applicant for Paragon Adult Maxi PMP Oxygenator with Tubing Pack?

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

What is the FDA product code for Paragon Adult Maxi PMP Oxygenator with Tubing Pack?

The FDA product code for Paragon Adult Maxi PMP Oxygenator with Tubing Pack is DTZ.

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Outros registros que listam Chalice Medical , Ltd. como candidato(a)

K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

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Fonte oficial

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