FDA 510(k)

VersaPAP Positive Airway Pressure (PAP) Device

Número K: K173918 · 2018-08-17

Data da decisão2018-08-17

Código do produtoBWF

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

VersaPAP Positive Airway Pressure (PAP) 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 2018-08-17 under 510(k) number K173918. 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 VersaPAP Positive Airway Pressure (PAP) Device?

VersaPAP Positive Airway Pressure (PAP) Device is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Trudell Medical International. The 510(k) number is K173918.

When did VersaPAP Positive Airway Pressure (PAP) Device receive FDA 510(k) clearance?

VersaPAP Positive Airway Pressure (PAP) Device received FDA 510(k) clearance on 2018-08-17, under 510(k) number K173918.

Who is the listed applicant for VersaPAP Positive Airway Pressure (PAP) 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 VersaPAP Positive Airway Pressure (PAP) Device?

The FDA product code for VersaPAP Positive Airway Pressure (PAP) Device is BWF.

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Fonte oficial

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