K254209
- 510(k) number
- K254209
- Device name
- Radius VSM and Accessories
- Applicant
- Masimo Corporation CA · US
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2026-06-04
- Date received
- 2025-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K254209.pdf
Official FDA record: K254209
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.