510(k) K243225

Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) by Genadyne Biotechnologies, Inc. — Product Code BZD

K243225 is an FDA 510(k) premarket notification submitted by Genadyne Biotechnologies, Inc. for the device "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 issued a decision of Substantially Equivalent on December 31, 2024. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Genadyne Biotechnologies, Inc. has at least 10 other 510(k) clearances on record.