Fisher and Paykel Healthcare Limited
FDA 510(k) & PMA Approved Devices — 3 products
Total Devices3
Categories3
Latest FDA decision2024-08-23
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K233829 | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) | BZD | 2024-08-23 | View |
| 510(k) | K173060 | F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version | CBK | 2018-01-25 | View |
| 510(k) | K170367 | Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small | MNT | 2017-08-24 | View |
No matching devices.
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