Masimo O3 Regional Oximeter System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K162603 FDA 510(k)
- FDA Product Code
- MUD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Masimo O3 Regional Oximeter System is a medical device classified as an Oximeter, Tissue Saturation, designed to measure regional tissue oxygenation levels. It provides continuous, noninvasive monitoring of oxygen saturation in specific body regions, such as the brain, muscle, or other tissues, to assess perfusion and oxygen delivery beyond what traditional pulse oximetry can offer. This capability supports clinical decision-making in critical care, anesthesia, and surgical settings where regional oxygenation trends are critical.
The system is supplied as a reusable medical device and is intended for use in clinical environments where advanced monitoring is required. It operates using Masimo’s proprietary technology to deliver accurate, real-time data on regional oxygen saturation (rSO₂), with multiple sensor options for different anatomical sites. The device is regulated under FDA 510(k) clearance (K162603) and falls under the Cardiovascular advisory committee classification. Storage and handling follow standard medical device protocols to maintain performance and sterility.
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 - Cerebral Oximetry, Masimo - Clinical Evidence - Regional Oximetry (O3), Masimo - Wikipedia, MASIMO O3 OPERATOR'S MANUAL Pdf Download | ManualsLib, Masimo - Startseite
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162603 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA 510(k) K162603 24 fields · synced Sep 20, 2026