FDA Registration
Active
🇺🇸 United States
AureFlo Monitoring System
Reg #: 1319030
·
FEI: 1319030
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TRANSONIC SYSTEMS, INC.
- Registration Number
- 1319030
- FEI Number
- 1319030
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 34 Dutch Mill Rd
- City
- ITHACA
- State
- NY
- ZIP
- 14850
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112657
Owner / Operator
- Firm Name
- TRANSONIC SYSTEMS, INC.
- Operator Number
- 1319030
- Address
- 34 Dutch Mill Road
- City
- Ithaca
- State
- NY
- Postal Code
- 14850
- Country
- US
- Correspondent
- Elizabeth Emig-Rosekrans
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2011-12-30 |
Proprietary Names
AureFlo Monitoring System
Establishment Types
Manufacture Medical Device