FDA Registration
Active
🇺🇸 United States
PURSUANT HEALTH
Reg #: 3012540196
·
FEI: 3012540196
·
Expires 2026
Products
4
Proprietary Names
3
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- PURSUANT HEALTH
- Registration Number
- 3012540196
- FEI Number
- 3012540196
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 11350 Old Roswell Rd, Suite 900
- City
- Alpharetta
- State
- GA
- ZIP
- 30009
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113402
Owner / Operator
- Firm Name
- Pursuant Health
- Operator Number
- 10024427
- Address
- 11350 Old Roswell Rd, Suite 900
- City
- Alpharetta
- State
- GA
- Postal Code
- 30009
- Country
- US
- Correspondent
- Stephanie Patrick
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2013-01-07 |
| Chart, Visual Acuity | HOX | Class 1 | Ophthalmic | No | 2013-01-07 |
| Refractometer, Ophthalmic | HKO | Class 1 | Ophthalmic | No | 2008-01-30 |
| Camera, Ophthalmic, Non-Prescription | QZP | Class 2 | Ophthalmic | No | 2024-01-09 |
Proprietary Names
SoloHealth Station
EyeSite
Pursuant Health Kiosk
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Remanufacture Medical Device
Manufacture Medical Device