FDA 510(k)

Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter

K-Number: K162675 · 2016-12-28

Decision Date2016-12-28

Product CodeDQA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2016-12-28 under 510(k) 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. The listed applicant is Masimo Corporation. The 510(k) number is K162675.

When did Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter receive FDA 510(k) clearance?

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

Who is the listed applicant for Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter?

The FDA 510(k) record lists Masimo Corporation as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETED NCT07223177Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric PopulationsRECRUITING NCT05977686Hemoglobin Testing in Pregnant PatientsRECRUITING NCT06148623Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin PigmentationCOMPLETED NCT06232876Continuous Versus Intermittent Ward MonitoringNOT_YET_RECRUITING NCT02986789Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical OutcomesTERMINATED

Other records listing Masimo Corporation as applicant

K260880SedLine Sedation Monitor K254209Radius VSM and Accessories K243324Masimo O3 Regional Oximeter K250757Radius VSM and Accessories K243305Masimo W1 K240229Masimo W1

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Related Devices (Code: DQA)

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbH K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin Systeme K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita Corporation K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

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.