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FDA 510(k)

Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter

K-Number: K162675 · 2016-12-28

ApplicantMasimo Corporation
Decision Date2016-12-28
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2016-12-28 under approval number K162675. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter?

Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is a medical device that received FDA 510(k) clearance on 2016-12-28. It is manufactured by Masimo Corporation. The 510(k) number is K162675.

When was Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter approved by the FDA?

Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter received FDA 510(k) clearance on 2016-12-28, under approval number K162675.

What company makes Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter?

Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is manufactured by Masimo Corporation.

What is the FDA product code for Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter?

The FDA product code for Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is DQA.

Related Clinical Trials

NCT07260890 Paired Comparison of SVV and PVI Accuracy COMPLETED NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT06432881 Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE) RECRUITING NCT05914324 Outpatient Pediatric Pulse Oximeters in Africa ACTIVE_NOT_RECRUITING NCT05690633 Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx COMPLETED

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Related Devices (Code: DQA)

K160231Model X-100C CO-Met™ Oximetry SystemNonin Medical, Inc. K160940Masimo Disposable Transflectance Forehead SensorMasimo Corporation K153021Fingertip Pulse Oximeter A310Amemo, Inc. K160268Fingertip Pulse Oximeter MD300CG11/MD300CG51Beijing Choice Electronic Technology Co., Ltd. K161560Fingertip Pulse Oximeter MD300CN310Beijing Choice Electronic Technology Co., Ltd. K160582WiCapAthena Gtx

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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