The following data is part of a premarket notification filed by Breathe Technologies, Inc. with the FDA for Breathe Technologies Ventilator And Accessories (bt-v2s).
| Device ID | K103345 |
| 510k Number | K103345 |
| Device Name: | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) |
| Classification | Mechanical Ventilator |
| Applicant | BREATHE TECHNOLOGIES, INC. 4000 EXECUTIVE PARKWAY, SUITE 190 San Ramon, CA 94583 |
| Contact | Joseph Cipillone |
| Correspondent | Joseph Cipillone BREATHE TECHNOLOGIES, INC. 4000 EXECUTIVE PARKWAY, SUITE 190 San Ramon, CA 94583 |
| Product Code | ONZ |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-15 |
| Decision Date | 2011-02-11 |
| Summary: | summary |