FDA 510(k)

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)

Número K: K200723 · 2020-06-26

Data da decisão2020-06-26

Código do produtoPGW

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2020-06-26 under 510(k) number K200723. The device is classified under product code PGW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is a medical device that received FDA 510(k) clearance on 2020-06-26. The listed applicant is Medtronic Navigation, Inc.. The 510(k) number is K200723.

When did StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) receive FDA 510(k) clearance?

StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) received FDA 510(k) clearance on 2020-06-26, under 510(k) number K200723.

Who is the listed applicant for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

The FDA 510(k) record lists Medtronic Navigation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)?

The FDA product code for StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) is PGW.

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Outros registros que listam Medtronic Navigation, Inc. como candidato(a)

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Dispositivos Relacionados (Código: PGW)

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Fonte oficial

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