FDA Registration
Active
🇺🇸 United States
PHASOR HEALTH, LLC
Reg #: 3016577622
·
FEI: 3016577622
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
3
Classifications
5
Registration Details
- Registration Name
- PHASOR HEALTH, LLC
- Registration Number
- 3016577622
- FEI Number
- 3016577622
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8944 Kirby Drive
- City
- Houston
- State
- TX
- ZIP
- 77054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K243205
Owner / Operator
- Firm Name
- Phasor Health, LLC
- Operator Number
- 10062497
- Address
- 8944 Kirby Drive
- City
- Houston
- State
- TX
- Postal Code
- 77054
- Country
- US
- Correspondent
- Ray King
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2025-08-13 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2025-08-13 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2025-11-21 |
| Neurological Tray | OJG | Class 1 | Neurology | No | 2024-10-22 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2025-11-22 |
Proprietary Names
EVAC
EZ-Fiducials
Green
Phasor Kit
PHASOR
LEGACY
EVAC-MRI
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility