The following data is part of a premarket notification filed by Breathe Technologies with the FDA for Breathe Niov Ventilation System.
| Device ID | K131562 |
| 510k Number | K131562 |
| Device Name: | BREATHE NIOV VENTILATION SYSTEM |
| Classification | Mechanical Ventilator |
| Applicant | BREATHE TECHNOLOGIES 1193 SHERMAN ST Alameda, CA 94501 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs BREATHE TECHNOLOGIES 1193 SHERMAN ST Alameda, CA 94501 |
| Product Code | ONZ |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-30 |
| Decision Date | 2014-03-06 |
| Summary: | summary |