The following data is part of a premarket notification filed by Breathe Technologies, Inc. with the FDA for Breathe Cpap System.
| Device ID | K130037 |
| 510k Number | K130037 |
| Device Name: | BREATHE CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | BREATHE TECHNOLOGIES, INC. 175 Technology Dr Ste 100 Irvine, CA 92618 |
| Contact | Craig Coombs |
| Correspondent | Craig Coombs BREATHE TECHNOLOGIES, INC. 175 Technology Dr Ste 100 Irvine, CA 92618 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-07 |
| Decision Date | 2013-05-17 |
| Summary: | summary |