FDA Registration
Active
🇺🇸 United States
TrackX
Reg #: 2027062
·
FEI: 2027062
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- BIOSEAL
- Registration Number
- 2027062
- FEI Number
- 2027062
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 167 WEST ORANGETHORPE AVE.
- City
- PLACENTIA
- State
- CA
- ZIP
- 92870
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173736
Owner / Operator
- Firm Name
- BIOSEAL
- Operator Number
- 2027062
- Address
- 167 WEST ORANGETHORPE AVE., --
- City
- Placentia
- State
- CA
- Postal Code
- 92870
- Country
- US
- Correspondent
- WILLIAM L RUNION
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2018-05-08 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2018-05-08 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-05-08 |
Proprietary Names
TrackX
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)