FDA 510(k)

Trusana

K-Number: K230098 · 2023-04-13

Decision Date2023-04-13

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Trusana is a medical device manufactured by Myerson, LLC. It received FDA 510(k) clearance on 2023-04-13 under approval 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. It is manufactured by Myerson, LLC. The 510(k) number is K230098.

When was Trusana approved by the FDA?

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

What company makes Trusana?

Trusana is manufactured by Myerson, LLC.

What is the FDA product code for Trusana?

The FDA product code for Trusana is EBI.

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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.