Data / Medical devices / United States / Physician Software Systems, LLC
Physician Software Systems, LLC: FDA-registered device maker in Lisle, IL, United States, 2 510(k) clearances
Physician Software Systems, LLC is registered with the FDA (registration 3010728384) in Lisle, IL, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated December 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010728384
- Address
- 3333 Warrenville Rd Ste 200, Lisle, IL, United States, 60532
- Owner or operator
- Physician Software Systems, LLC (10045966)
- Roles
- Manufacturer
- First device listed
- January 17, 2014
- Registered through
- 2026
- Brand names listed
- PhySoftAMS®
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Hemodialysis, Access Recirculation Monitoring | MQS | 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 |
|---|---|---|---|---|---|---|
| December 14, 2023 | K232283 | PhySoftAMS® | MQS | Substantially Equivalent | Physician Software Systems, LLC | accessdata.fda.gov |
| December 19, 2013 | K130579 | PHYSOFT AMS | MQS | Substantially Equivalent | Physicians Software Systems, LLC | accessdata.fda.gov |
Updated December 14, 2023. 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.