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FDA 510(k)

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue

K-Number: K232389 · 2023-09-07

ApplicantMasimo Corporation
Decision Date2023-09-07
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2023-09-07 under approval number K232389. 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 Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue?

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue is a medical device that received FDA 510(k) clearance on 2023-09-07. It is manufactured by Masimo Corporation. The 510(k) number is K232389.

When was Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue approved by the FDA?

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue received FDA 510(k) clearance on 2023-09-07, under approval number K232389.

What company makes Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue?

Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue is manufactured by Masimo Corporation.

What is the FDA product code for Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue?

The FDA product code for Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue is DQA.

Other Devices by Masimo Corporation

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Related Devices (Code: DQA)

K162675Masimo Rainbow SET Intellivue Module Pulse CO-OximeterMasimo Corporation 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.

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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