FDA 510(k)

iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask

Número K: K241469 · 2024-06-15

Data da decisão2024-06-15

Código do produtoBZD

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask is the device name listed in this FDA 510(k) record. The listed applicant is Sleepnet Corporation. It received FDA 510(k) clearance on 2024-06-15 under 510(k) number K241469. 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 iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask?

iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask is a medical device that received FDA 510(k) clearance on 2024-06-15. The listed applicant is Sleepnet Corporation. The 510(k) number is K241469.

When did iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask receive FDA 510(k) clearance?

iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask received FDA 510(k) clearance on 2024-06-15, under 510(k) number K241469.

Who is the listed applicant for iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask?

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

What is the FDA product code for iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask?

The FDA product code for iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask is BZD.

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Fonte oficial

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