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FDA 510(k)

Temporis, Irix Plus

K-Number: K231142 · 2024-04-25

ApplicantDws S.R.L.
Decision Date2024-04-25
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Temporis, Irix Plus is a medical device manufactured by Dws S.R.L.. It received FDA 510(k) clearance on 2024-04-25 under approval number K231142. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Temporis, Irix Plus?

Temporis, Irix Plus is a medical device that received FDA 510(k) clearance on 2024-04-25. It is manufactured by Dws S.R.L.. The 510(k) number is K231142.

When was Temporis, Irix Plus approved by the FDA?

Temporis, Irix Plus received FDA 510(k) clearance on 2024-04-25, under approval number K231142.

What company makes Temporis, Irix Plus?

Temporis, Irix Plus is manufactured by Dws S.R.L..

What is the FDA product code for Temporis, Irix Plus?

The FDA product code for Temporis, Irix Plus is EBF.

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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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