FDA Registration
Active
🇺🇸 United States
Certus 140 2.45GHz Ablation System with Ablation Confirmation Software
Reg #: 3008769756
·
FEI: 3008769756
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- NEUWAVE MEDICAL, INC.
- Registration Number
- 3008769756
- FEI Number
- 3008769756
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3529, 3513(Suite 100) and 3543 Anderson Street
- City
- Madison
- State
- WI
- ZIP
- 53704
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192427
Owner / Operator
- Firm Name
- NeuWave Medical, Inc.
- Operator Number
- 10034016
- Address
- 3529 Anderson Street
- City
- Madison
- State
- WI
- Postal Code
- 53704
- Country
- US
- Correspondent
- Emily Nesbitt
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2019-10-17 |
Proprietary Names
Certus 140 2.45GHz Ablation System with Ablation Confirmation Software
NEUWAVE Microwave Ablation System with Ablation Confirmation Software
Establishment Types
Manufacture Medical Device