The following data is part of a premarket notification filed by Vapotherm, Inc. with the FDA for Vapotherm 2000h.
| Device ID | K013486 |
| 510k Number | K013486 |
| Device Name: | VAPOTHERM 2000H |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | VAPOTHERM, INC. 6329 W.WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden VAPOTHERM, INC. 6329 W.WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | BTT |
| Subsequent Product Code | BTI |
| Subsequent Product Code | BZR |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-19 |
| Decision Date | 2003-05-30 |
| Summary: | summary |