Fisher and Paykel Healthcare Limited
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 11
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243583 | F&P Nova Nasal Mask | June 18, 2025 |
| K233829 | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nov | August 23, 2024 |
| K211560 | Airvo Nebulizer Adapter | December 10, 2021 |
| K191624 | F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version | March 9, 2020 |
| K173770 | OJR215 Pressure Relief Manifold | April 5, 2019 |
| K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version | January 25, 2018 |
| K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non- | August 24, 2017 |
| K153505 | F&P Eson 2 Nasal Mask | September 20, 2016 |
| K130328 | F&P SIMPLUS FULL FACE MASK | June 5, 2013 |
| K121597 | ESON NASAL MASK | October 2, 2012 |
| K120027 | PILAIRO NASAL PILLOWS MASK | February 23, 2012 |