The following data is part of a premarket notification filed by Vapotherm Inc. with the FDA for Vapotherm Aerosol Adapter Aaa-2.
| Device ID | K220869 |
| 510k Number | K220869 |
| Device Name: | Vapotherm Aerosol Adapter AAA-2 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Vapotherm Inc. 100 Domain Drive Exeter, NH 03833 |
| Contact | Michael J. Webb |
| Correspondent | Michael J. Webb Vapotherm Inc. 100 Domain Drive Exeter, NH 03833 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-25 |
| Decision Date | 2022-10-28 |