FDA 510(k)

AirPhysio Dispositivo de Pressão Positiva de Expiração (PEP)

Número K: K203209 · 2021-01-15

Data da decisão2021-01-15

Código do produtoBYI

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

AirPhysio Positive Expiratory Pressure (PEP) Device is the device name listed in this FDA 510(k) record. The listed applicant is Airphysio Pty, Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203209. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AirPhysio Positive Expiratory Pressure (PEP) Device?

AirPhysio Positive Expiratory Pressure (PEP) Device is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Airphysio Pty, Ltd.. The 510(k) number is K203209.

When did AirPhysio Positive Expiratory Pressure (PEP) Device receive FDA 510(k) clearance?

AirPhysio Positive Expiratory Pressure (PEP) Device received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203209.

Who is the listed applicant for AirPhysio Positive Expiratory Pressure (PEP) Device?

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

What is the FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device?

The FDA product code for AirPhysio Positive Expiratory Pressure (PEP) Device is BYI.

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