The following data is part of a premarket notification filed by Vapotherm, Inc. with the FDA for Vapotherm Model# 2000i And 2000h.
| Device ID | K070056 |
| 510k Number | K070056 |
| Device Name: | VAPOTHERM MODEL# 2000I AND 2000H |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | VAPOTHERM, INC. 555 THIRTEENTH STREET, NW Washington, DC 21666 |
| Contact | Johnathan Kahan |
| Correspondent | Johnathan Kahan VAPOTHERM, INC. 555 THIRTEENTH STREET, NW Washington, DC 21666 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-05 |
| Decision Date | 2007-04-13 |
| Summary: | summary |