FDA Registration
Active
🇸🇪 Sweden
TetraGraph Neuromuscular Transmission Monitor (NMT)
Reg #: 3016490024
·
FEI: 3016490024
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- SENZIME AB
- Registration Number
- 3016490024
- FEI Number
- 3016490024
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Verkstadsgatan 8
- City
- Uppsala
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K190795
Owner / Operator
- Firm Name
- Senzime AB
- Operator Number
- 10062527
- Address
- Verkstadsgatan 8
- City
- Uppsala
- State
- SE-C
- Postal Code
- 75323
- Country
- SE
- Correspondent
- Johanna Faris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2020-02-07 |
Proprietary Names
TetraGraph Neuromuscular Transmission Monitor (NMT)
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198