The following data is part of a premarket notification filed by Tf Health Co. with the FDA for Breezing Med.
| Device ID | K200076 |
| 510k Number | K200076 |
| Device Name: | Breezing Med |
| Classification | Computer, Oxygen-uptake |
| Applicant | TF Health Co. 1761 W. University Dr., Suite 140 Tempe, AZ 85281 |
| Contact | Erik Herrmann |
| Correspondent | Roberta (bobbi) Druyor-sanchez NDA Partners 1761 W. University Dr., Suite 140 Tempe, AZ 85281 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-14 |
| Decision Date | 2020-09-25 |