K253436
- 510(k) number
- K253436
- Device name
- c-med0 alpha
- Applicant
- Cosinuss GmbH DE
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2026-04-30
- Date received
- 2025-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K253436.pdf
Official FDA record: K253436
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.