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FDA 510(k)

Radius VSM and Accessories

K-Number: K250757 · 2025-05-29

ApplicantMasimo Corporation
Decision Date2025-05-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Radius VSM and Accessories is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2025-05-29 under approval number K250757. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radius VSM and Accessories?

Radius VSM and Accessories is a medical device that received FDA 510(k) clearance on 2025-05-29. It is manufactured by Masimo Corporation. The 510(k) number is K250757.

When was Radius VSM and Accessories approved by the FDA?

Radius VSM and Accessories received FDA 510(k) clearance on 2025-05-29, under approval number K250757.

What company makes Radius VSM and Accessories?

Radius VSM and Accessories is manufactured by Masimo Corporation.

What is the FDA product code for Radius VSM and Accessories?

The FDA product code for Radius VSM and Accessories is MHX.

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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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