FDA Registration
Active
🇨🇭 Switzerland
Easy on-PC Spirometer
Reg #: 3003318787
·
FEI: 3003318787
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- VARIOSYSTEMS AG
- Registration Number
- 3003318787
- FEI Number
- 3003318787
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Amperestr. 5
- City
- Steinach Sankt Gallen
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K090034
Owner / Operator
- Firm Name
- Variosystems AG
- Operator Number
- 10044977
- Address
- Amperestr. 5
- City
- Steinach
- State
- Sankt Gallen
- Postal Code
- 9323
- Country
- CH
- Correspondent
- Johannes Sicher
US Agent
- Business Name
- Variosystems Inc.
- Contact Name
- Ryan Rebstock
- Address
- 901 S Kimball Ave
- City
- Southlake
- State
- TX
- ZIP
- 76092
- Country
- US
- [email protected]
- Phone
- 817 5523378
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2018-07-12 |
Proprietary Names
Easy on-PC Spirometer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)