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ORi

FDA 510(k)

Class II (US FDA 510(k))

510(k) DEN200076

by Masimo Corporation

Identifiers

510(k) Number
DEN200076 FDA 510(k)
FDA Product Code
QWE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2720 FDA 510(k)
Regulation Number
870.2720 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
DENG FDA 510(k)

The ORi is a Hyperoxia Monitoring Device used as an adjunct to pulse oximetry. It is classified as a class 2 device. The device is used in the field of Anesthesiology.

The ORi is supplied with regulatory authorizations including FDA 510K clearance. It is intended for use in monitoring hyperoxia under supplemental oxygen, with associated product codes and registration numbers. The device is associated with the medical specialty of Anesthesiology and is regulated under the number 870.2720.

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, RD rainbow Adt 8λ LiDCO SpHb ORi Adhesive Sensor - techdocs.masimo.com, Masimo ORi™ Granted De Novo as the First and Only FDA-Cleared ... - ADVFN

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Masimo Corporation

Sources (1)

  • FDA 510(k) DEN200076 24 fields · synced Sep 22, 2026