FDA 510(k)

Masimo Centroid System

K-Number: K191882 · 2020-04-22

Decision Date2020-04-22

Product CodeMWI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Masimo Centroid System is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2020-04-22 under approval number K191882. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Masimo Centroid System?

Masimo Centroid System is a medical device that received FDA 510(k) clearance on 2020-04-22. It is manufactured by Masimo Corporation. The 510(k) number is K191882.

When was Masimo Centroid System approved by the FDA?

Masimo Centroid System received FDA 510(k) clearance on 2020-04-22, under approval number K191882.

What company makes Masimo Centroid System?

Masimo Centroid System is manufactured by Masimo Corporation.

What is the FDA product code for Masimo Centroid System?

The FDA product code for Masimo Centroid System is MWI.

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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.