K250634
- 510(k) number
- K250634
- Device name
- BCM2-Body Composition Monitor
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC MA · US
- Product code
- DSB — Plethysmograph, Impedance
- Decision date
- 2025-11-24
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K250634.pdf
Official FDA record: K250634
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.