FDA 510(k)

Combined Aerobika OPEP and VersaPAP device

Número K: K183108 · 2019-08-16

Data da decisão2019-08-16

Código do produtoBWF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Combined Aerobika OPEP and VersaPAP device is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2019-08-16 under 510(k) number K183108. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Combined Aerobika OPEP and VersaPAP device?

Combined Aerobika OPEP and VersaPAP device is a medical device that received FDA 510(k) clearance on 2019-08-16. The listed applicant is Trudell Medical International. The 510(k) number is K183108.

When did Combined Aerobika OPEP and VersaPAP device receive FDA 510(k) clearance?

Combined Aerobika OPEP and VersaPAP device received FDA 510(k) clearance on 2019-08-16, under 510(k) number K183108.

Who is the listed applicant for Combined Aerobika OPEP and VersaPAP device?

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

What is the FDA product code for Combined Aerobika OPEP and VersaPAP device?

The FDA product code for Combined Aerobika OPEP and VersaPAP device is BWF.

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Fonte oficial

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