The following data is part of a premarket notification filed by Breathe Technologies with the FDA for Breathe Technologies Life2000 Ventilation System.
| Device ID | K141943 |
| 510k Number | K141943 |
| Device Name: | BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BREATHE TECHNOLOGIES 175 TECHNOLOGY DR, SUITE 100 Irvine, CA 92618 |
| Contact | Samir Ahmad |
| Correspondent | Craig Coombs BREATHE TECHNOLOGIES 1193 SHERMAN ST Alameda, CA 94501 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-17 |
| Decision Date | 2015-06-12 |
| Summary: | summary |