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

About This 510(k) Submission

K243225 is an FDA 510(k) clearance for 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), a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Genadyne Biotechnologies, Inc. (Hicksville, US). The FDA issued a Cleared decision on December 31, 2024, 84 days after receiving the submission on October 8, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.