Respironics, Inc.
FDA 510(k) & PMA Approved Devices — 15 products
Total Devices15
Categories5
Latest Approval2024-12-30
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K243394 | AF531 Oro-Nasal SE Face Mask | CBK | 2024-12-30 | View |
| 510(k) | K231313 | Therapy Mask 3100 NC/SP | BZD | 2023-07-28 | View |
| 510(k) | K210844 | DreamWear Silicone Pillows Mask | BZD | 2021-08-24 | View |
| 510(k) | K210386 | Magneto Nasal Mask | BZD | 2021-07-12 | View |
| 510(k) | K202142 | Sleepware G3 | OLZ | 2020-10-29 | View |
| 510(k) | K201439 | Ventilator, Non-continuous (Respirator) | BZD | 2020-09-25 | View |
| 510(k) | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | BZD | 2020-07-10 | View |
| 510(k) | K183226 | Care Orchestrator Essence | BZD | 2019-10-18 | View |
| 510(k) | K183625 | SomnaPatch | MNR | 2019-10-18 | View |
| 510(k) | K181166 | Trilogy Evo | CBK | 2019-07-18 | View |
| 510(k) | K181170 | Trilogy Evo Universal | CBK | 2019-07-18 | View |
| 510(k) | K181053 | Care Orchestrator | BZD | 2019-01-04 | View |
| 510(k) | K161411 | Care Cycle Connect Application | MOD | 2017-02-17 | View |
| 510(k) | K151120 | Simple T Pediatric Nasal Mask | BZD | 2016-04-15 | View |
| 510(k) | K152356 | Sapphire | BZD | 2016-01-08 | View |
No matching devices.