K252173
- 510(k) number
- K252173
- Device name
- F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
- Applicant
- Fisher & Paykel Healthcare, Ltd. NZ
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2025-09-10
- Date received
- 2025-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K252173.pdf
Official FDA record: K252173
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.