K243225
- 510(k) number
- K243225
- Device name
- Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
- Applicant
- Genadyne Biotechnologies, Inc. NY · US
- Product code
- BZD — Ventilator, Non-Continuous (Respirator)
- Decision date
- 2024-12-31
- Date received
- 2024-10-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243225.pdf
Official FDA record: K243225
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.