FDA Registration
Active
🇺🇸 United States
Precision Flow Heliox
Reg #: 3012971441
·
FEI: 3012971441
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Vapotherm Inc.
- Registration Number
- 3012971441
- FEI Number
- 3012971441
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 100 Domain Dr
- City
- Exeter
- State
- NH
- ZIP
- 03833
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111640
Owner / Operator
- Firm Name
- VAPOTHERM, INC.
- Operator Number
- 9038880
- Address
- 100 Domain Drive, --
- City
- Exeter
- State
- NH
- Postal Code
- 03833
- Country
- US
- Correspondent
- Neeraj Pardhy
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2011-11-16 |
Proprietary Names
Precision Flow Heliox
Establishment Types
Manufacture Medical Device