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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 the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2024-01-31 under 510(k) 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. The listed applicant is Masimo Corporation. The 510(k) number is K214115.

When did MightySat -OTC receive FDA 510(k) clearance?

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

Who is the listed applicant for MightySat -OTC?

The FDA 510(k) record lists Masimo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MightySat -OTC?

The FDA product code for MightySat -OTC is OLK.

Related Clinical Trials

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Other records listing Masimo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OLK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc.

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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