K232089
- 510(k) number
- K232089
- Device name
- SOZO Pro
- Applicant
- ImpediMed Limited AU
- Product code
- DSB — Plethysmograph, Impedance
- Decision date
- 2023-10-17
- Date received
- 2023-07-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232089.pdf
Official FDA record: K232089
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.