The following data is part of a premarket notification filed by Vapotherm, Inc. with the FDA for Vapotherm, Model 2000i.
| Device ID | K000401 |
| 510k Number | K000401 |
| Device Name: | VAPOTHERM, MODEL 2000I |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | VAPOTHERM, INC. 163 CONDUIT ST. Annapolis, MD 21401 |
| Contact | William Niland |
| Correspondent | William Niland VAPOTHERM, INC. 163 CONDUIT ST. Annapolis, MD 21401 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-07 |
| Decision Date | 2000-08-24 |