K253224
- 510(k) number
- K253224
- Device name
- MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
- Applicant
- ImpediMed Limited AU
- Product code
- OBH — Monitor, Extracellular Fluid, Lymphedema, Extremity
- Decision date
- 2026-01-28
- Date received
- 2025-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253224.pdf
Official FDA record: K253224
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.