FDA 510(k)

Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)

Número K: K243225 · 2024-12-31

RequerenteGenadyne Biotechnologies, Inc.

Data da decisão2024-12-31

Código do produtoBZD

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) is the device name listed in this FDA 510(k) record. The listed applicant is Genadyne Biotechnologies, Inc.. It received FDA 510(k) clearance on 2024-12-31 under 510(k) number K243225. 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 Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)?

Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) is a medical device that received FDA 510(k) clearance on 2024-12-31. The listed applicant is Genadyne Biotechnologies, Inc.. The 510(k) number is K243225.

When did Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) receive FDA 510(k) clearance?

Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) received FDA 510(k) clearance on 2024-12-31, under 510(k) number K243225.

Who is the listed applicant for Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)?

The FDA 510(k) record lists Genadyne Biotechnologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)?

The FDA product code for Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) is BZD.

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Fonte oficial

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