Nasal Pillow Mask – Small (NNPM-01/ Nefes S); Nasal Pillow Mask – Medium (NNPM-02/ Nefes M); Nasal Pillow Mask – Large (NNPM-03/ Nefes L) (K243225)
Description
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., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243225
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Nasal Pillow Mask – Small (NNPM-01/ Nefes S); Nasal Pillow Mask – Medium (NNPM-02/ Nefes M); Nasal Pillow Mask – Large (NNPM-03/ Nefes L) (K243225) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K120920 | HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASA... | Hsiner Company | 2012 |
Trace the full predicate network for K243225
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.