FDA 510(k)

Máscara Facial AF531 Oro-Nasal EE Fuga 1; Máscara Facial AF531 Oro-Nasal EE Fuga 2

Número K: K233555 · 2024-07-31

Data da decisão2024-07-31

Código do produtoBZD

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Philips Respironics. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K233555. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask?

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Philips Respironics. The 510(k) number is K233555.

When did AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask receive FDA 510(k) clearance?

AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask received FDA 510(k) clearance on 2024-07-31, under 510(k) number K233555.

Who is the listed applicant for AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask?

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

What is the FDA product code for AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask?

The FDA product code for AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask is BZD.

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