K253417
- 510(k) number
- K253417
- Device name
- Masimo Root Monitoring System
- Applicant
- Masimo Corporation CA · US
- Product code
- MWI — Monitor, Physiological, Patient (Without Arrhythmia
- Decision date
- 2026-08-12
- Date received
- 2025-10-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K253417.pdf
Official FDA record: K253417
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.