Data / Medical devices / United States / Pursuant Health
Pursuant Health: FDA-registered device maker in Alpharetta, GA, United States, 2 510(k) clearances
Pursuant Health is registered with the FDA (registration 3012540196) in Alpharetta, GA, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012540196
- Address
- 11350 Old Roswell Rd Suite 900, Alpharetta, GA, United States, 30009
- Owner or operator
- Pursuant Health (10024427)
- Roles
- Manufacturer, Remanufacturer, Specification developer
- First device listed
- January 30, 2008
- Registered through
- 2026
- Brand names listed
- EyeSite, Pursuant Health Kiosk, SoloHealth Station
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Ophthalmic, Non-Prescription | QZP | 2 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Chart, Visual Acuity | HOX | 1 | Specification developer | accessdata.fda.gov |
| Refractometer, Ophthalmic | HKO | 1 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer, Remanufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 4, 2024 | K230996 | Pursuant Health Kiosk (G1.D5) | DXN | Substantially Equivalent | Pursuant Health | accessdata.fda.gov |
| May 30, 2012 | K113402 | SOLOHEALTH STATION | DXN | Substantially Equivalent | Solohealth, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Refractometer, Ophthalmic
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Chart, Visual Acuity
Updated January 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.