The following data is part of a premarket notification filed by Vapotherm Inc. with the FDA for Hvt 2.0.
| Device ID | K203357 |
| 510k Number | K203357 |
| Device Name: | HVT 2.0 |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | Vapotherm Inc. 100 Domain Drive Exeter, NH 03833 |
| Contact | Dennis Francoeur |
| Correspondent | Dennis Francoeur Vapotherm Inc. 100 Domain Drive Exeter, NH 03833 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-16 |
| Decision Date | 2021-08-25 |