The following data is part of a premarket notification filed by Vapotherm, Inc. with the FDA for Palladium High Flow Therapy System.
| Device ID | K191010 |
| 510k Number | K191010 |
| Device Name: | Palladium High Flow Therapy System |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | Vapotherm, Inc. 100 Domain Drive Exeter, NH 03833 |
| Contact | Richelle Helman |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-04-16 |
| Decision Date | 2019-10-10 |
| Summary: | summary |