K232283
- 510(k) number
- K232283
- Device name
- PhySoftAMS®
- Applicant
- Physician Software Systems, LLC IL · US
- Product code
- MQS — System, Hemodialysis, Access Recirculation Monitorin
- Decision date
- 2023-12-14
- Date received
- 2023-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232283.pdf
Official FDA record: K232283
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.