Fisher & Paykel Healthcare, Ltd.
FDA 510(k) & PMA Approved Devices — 25 products
Total Devices25
Categories7
Latest FDA decision2025-12-19
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | BTT | 2020-03-19 | View |
| 510(k) | K190713 | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) | BZD | 2019-10-11 | View |
| 510(k) | K173193 | F&P SleepStyle | BZD | 2018-08-08 | View |
| 510(k) | K161686 | F&P InfoSmart | BZD | 2017-01-24 | View |
| 510(k) | K161412 | F&P Brevida™ Nasal Pillows Mask | BZD | 2017-01-18 | View |
No matching devices.
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