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FDA 510(k)

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories

K-Number: K212161 · 2023-03-06

ApplicantMasimo Corporation
Decision Date2023-03-06
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2023-03-06 under approval number K212161. 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 Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories?

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is a medical device that received FDA 510(k) clearance on 2023-03-06. It is manufactured by Masimo Corporation. The 510(k) number is K212161.

When was Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories approved by the FDA?

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories received FDA 510(k) clearance on 2023-03-06, under approval number K212161.

What company makes Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories?

Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is manufactured by Masimo Corporation.

What is the FDA product code for Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories?

The FDA product code for Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories is MWI.

Related Clinical Trials

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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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