FDA 510(k)

Capnostream 35 Portable Respiratory Monitor

Número K: K200594 · 2020-04-27

RequerenteOridion Medical 1987 , Ltd.

Data da decisão2020-04-27

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Capnostream 35 Portable Respiratory Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Oridion Medical 1987 , Ltd.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K200594. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Capnostream 35 Portable Respiratory Monitor?

Capnostream 35 Portable Respiratory Monitor is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Oridion Medical 1987 , Ltd.. The 510(k) number is K200594.

When did Capnostream 35 Portable Respiratory Monitor receive FDA 510(k) clearance?

Capnostream 35 Portable Respiratory Monitor received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200594.

Who is the listed applicant for Capnostream 35 Portable Respiratory Monitor?

The FDA 510(k) record lists Oridion Medical 1987 , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capnostream 35 Portable Respiratory Monitor?

The FDA product code for Capnostream 35 Portable Respiratory Monitor is CCK.

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Dispositivos Relacionados (Código: CCK)

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Fonte oficial

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