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FDA 510(k)

MightySat -OTC

K-Number: K214115 · 2024-01-31

ApplicantMasimo Corporation
Decision Date2024-01-31
Product CodeOLK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MightySat -OTC is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2024-01-31 under approval number K214115. The device is classified under product code OLK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MightySat -OTC?

MightySat -OTC is a medical device that received FDA 510(k) clearance on 2024-01-31. It is manufactured by Masimo Corporation. The 510(k) number is K214115.

When was MightySat -OTC approved by the FDA?

MightySat -OTC received FDA 510(k) clearance on 2024-01-31, under approval number K214115.

What company makes MightySat -OTC?

MightySat -OTC is manufactured by Masimo Corporation.

What is the FDA product code for MightySat -OTC?

The FDA product code for MightySat -OTC is OLK.

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Related Devices (Code: OLK)

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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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