Data / Medical devices / United States / Pronia Medical Systems
Pronia Medical Systems: FDA-registered device maker in Lewisburg, PA, United States, 1 510(k) clearance
Pronia Medical Systems is registered with the FDA (registration 3014174631) in Lewisburg, PA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 21, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014174631
- FEI number
- 3028631080
- Address
- 803 Springhouse Dr, Lewisburg, PA, United States, 17837
- Owner or operator
- Pronia Medical Systems (10028182)
- Roles
- Manufacturer
- First device listed
- January 6, 2009
- Registered through
- 2026
- Brand names listed
- GlucoCare Intensive Glycemic Control System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Drug Dose | NDC | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 21, 2008 | K081388 | GLUCOCARE INTENSIVE GLYCEMIC CONTROL SYSTEM | NDC | Substantially Equivalent | Pronia Medical System, LLC | accessdata.fda.gov |
Compare with other makers
Updated August 21, 2008. 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.