Masimo O3 Regional Oximeter System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182429 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 designed for regional oximetry, measuring tissue saturation levels. It is classified as an oximeter and operates under the product code MUD, intended for cardiovascular applications.
The system is authorized under FDA 510K clearance with K-number K182429, received on September 6, 2018, and decided on June 7, 2019. It is manufactured by Masimo Corporation in Irvine, California, and is a Class II medical device. The system includes various registration numbers and is regulated under 870.2700.
Frequently asked questions
What is the Masimo O3 Regional Oximeter System used for?
The Masimo O3 Regional Oximeter System is designed for regional oximetry, measuring tissue saturation levels. It is classified as an oximeter intended for cardiovascular applications, providing clinicians with valuable data about tissue oxygenation.
What is the regulatory status of the Masimo O3 Regional Oximeter System?
The system is authorized under FDA 510K clearance with K-number K182429, received on September 6, 2018, and decided on June 7, 2019. It is manufactured by Masimo Corporation in Irvine, California, and is a Class II medical device regulated under 870.2700.
How is the Masimo O3 Regional Oximeter System supplied and what are its specifications?
The system includes various registration numbers and is manufactured by Masimo Corporation. It operates under the product code MUD and is designed for cardiovascular applications. The system provides measurements of tissue saturation levels, which is its primary function in clinical settings.
Is the Masimo O3 Regional Oximeter System reusable or single-use?
The device data does not specify whether the Masimo O3 Regional Oximeter System is reusable or single-use. For information regarding the intended use pattern and sterility, please consult the manufacturer's documentation or contact Masimo Corporation directly.
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 - Wikipedia, Masimo - Startseite, Masimo - Home
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182429 | Class II | Active |
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Manufacturer
- Manufacturer
- Masimo Corporation
Sources (1)
- FDA 510(k) K182429 24 fields · synced Sep 21, 2026