FDA 510(k)

ODI-Tech

K-Number: K241393 · 2024-08-30

Decision Date2024-08-30

Product CodeMUD

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ODI-Tech is the device name listed in this FDA 510(k) record. The listed applicant is Odi Medical AS. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K241393. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODI-Tech?

ODI-Tech is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Odi Medical AS. The 510(k) number is K241393.

When did ODI-Tech receive FDA 510(k) clearance?

ODI-Tech received FDA 510(k) clearance on 2024-08-30, under 510(k) number K241393.

Who is the listed applicant for ODI-Tech?

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

What is the FDA product code for ODI-Tech?

The FDA product code for ODI-Tech is MUD.

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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.