K240558
- 510(k) number
- K240558
- Device name
- NAVOYCDS
- Applicant
- Algodx AB SE
- Product code
- PLB — Multivariate Vital Signs Index
- Decision date
- 2024-07-22
- Date received
- 2024-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K240558.pdf
Official FDA record: K240558
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.