FDA 510(k)

Trusana™

K-Number: K230098 · 2023-04-13

Decision Date2023-04-13

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Trusana™ is the device name listed in this FDA 510(k) record. The listed applicant is Myerson, LLC. It received FDA 510(k) clearance on 2023-04-13 under 510(k) number K230098. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trusana™?

Trusana™ is a medical device that received FDA 510(k) clearance on 2023-04-13. The listed applicant is Myerson, LLC. The 510(k) number is K230098.

When did Trusana™ receive FDA 510(k) clearance?

Trusana™ received FDA 510(k) clearance on 2023-04-13, under 510(k) number K230098.

Who is the listed applicant for Trusana™?

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

What is the FDA product code for Trusana™?

The FDA product code for Trusana™ is EBI.

Related Devices (Code: EBI)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.