FDA 510(k)

CO2 Mainstream Sensor

Número K: K221118 · 2023-04-05

Data da decisão2023-04-05

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

CO2 Mainstream Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2023-04-05 under 510(k) number K221118. 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 CO2 Mainstream Sensor?

CO2 Mainstream Sensor is a medical device that received FDA 510(k) clearance on 2023-04-05. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K221118.

When did CO2 Mainstream Sensor receive FDA 510(k) clearance?

CO2 Mainstream Sensor received FDA 510(k) clearance on 2023-04-05, under 510(k) number K221118.

Who is the listed applicant for CO2 Mainstream Sensor?

The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Mainstream Sensor?

The FDA product code for CO2 Mainstream Sensor is CCK.

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Outros registros que listam Draegerwerk AG & CO Kgaa como candidato(a)

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Fonte oficial

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