Masimo Root Monitoring System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140188 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Masimo Root Monitoring System is a patient monitoring and connectivity hub that integrates various technologies, devices, and systems to provide multimodal monitoring solutions. It features an instantly interpretable, high visibility display with intuitive, multi-touch navigation for adaptable use in hospital environments.
The system integrates Masimo's measurements from the Radical-7 handheld or Radius-7 patient-worn monitor and offers flexible measurement expansion through Masimo Open Connect. It is authorized under FDA 510K clearance with product code MWI and was reviewed by the Cardiovascular advisory committee.
Frequently asked questions
What is the Masimo Root Monitoring System used for?
The Masimo Root Monitoring System is a patient monitoring and connectivity hub that integrates various technologies, devices, and systems to provide multimodal monitoring solutions in hospital environments.
How is the Masimo Root Monitoring System supplied?
The system integrates measurements from Masimo's Radical-7 handheld or Radius-7 patient-worn monitor and offers flexible measurement expansion through Masimo Open Connect technology.
What is the regulatory status of the Masimo Root Monitoring System?
The Masimo Root Monitoring System is authorized under FDA 510K clearance with product code MWI and was reviewed by the Cardiovascular advisory committee.
What are the key features of the Masimo Root Monitoring System?
The system features an instantly interpretable, high visibility display with intuitive, multi-touch navigation for adaptable use in various hospital settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Masimo - Root Platform, Masimo - Root - Noninvasive Blood Pressure and Temperature, Masimo - Wikipedia, MASIMO ROOT MANUAL Pdf Download | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K140188 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA 510(k) K140188 24 fields · synced Oct 1, 2026