K243727
- 510(k) number
- K243727
- Device name
- Re:Balans
- Applicant
- Mode Sensors AS NO
- Product code
- DSB — Plethysmograph, Impedance
- Decision date
- 2025-10-16
- Date received
- 2024-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243727.pdf
Official FDA record: K243727
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.