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FDA 510(k)

Masimo CARESCAPE SpO2 – Masimo with SpHb

K-Number: K221953 · 2022-08-04

ApplicantMasimo Corporation
Decision Date2022-08-04
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo CARESCAPE SpO2 – Masimo with SpHb is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2022-08-04 under approval number K221953. 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 CARESCAPE SpO2 – Masimo with SpHb?

Masimo CARESCAPE SpO2 – Masimo with SpHb is a medical device that received FDA 510(k) clearance on 2022-08-04. It is manufactured by Masimo Corporation. The 510(k) number is K221953.

When was Masimo CARESCAPE SpO2 – Masimo with SpHb approved by the FDA?

Masimo CARESCAPE SpO2 – Masimo with SpHb received FDA 510(k) clearance on 2022-08-04, under approval number K221953.

What company makes Masimo CARESCAPE SpO2 – Masimo with SpHb?

Masimo CARESCAPE SpO2 – Masimo with SpHb is manufactured by Masimo Corporation.

What is the FDA product code for Masimo CARESCAPE SpO2 – Masimo with SpHb?

The FDA product code for Masimo CARESCAPE SpO2 – Masimo with SpHb is DQA.

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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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