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FDA 510(k)

Carescape SpO2 - Masimo

K-Number: K212876 · 2021-10-08

ApplicantMasimo Corporation
Decision Date2021-10-08
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Carescape SpO2 - Masimo is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2021-10-08 under approval number K212876. 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?

Carescape SpO2 - Masimo is a medical device that received FDA 510(k) clearance on 2021-10-08. It is manufactured by Masimo Corporation. The 510(k) number is K212876.

When was Carescape SpO2 - Masimo approved by the FDA?

Carescape SpO2 - Masimo received FDA 510(k) clearance on 2021-10-08, under approval number K212876.

What company makes Carescape SpO2 - Masimo?

Carescape SpO2 - Masimo is manufactured by Masimo Corporation.

What is the FDA product code for Carescape SpO2 - Masimo?

The FDA product code for Carescape SpO2 - Masimo is DQA.

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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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