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FDA 510(k)

ODI-Tech

K-Number: K241393 · 2024-08-30

ApplicantOdi Medical AS
Decision Date2024-08-30
Product CodeMUD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ODI-Tech is a medical device manufactured by Odi Medical AS. It received FDA 510(k) clearance on 2024-08-30 under approval 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. It is manufactured by Odi Medical AS. The 510(k) number is K241393.

When was ODI-Tech approved by the FDA?

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

What company makes ODI-Tech?

ODI-Tech is manufactured by Odi Medical AS.

What is the FDA product code for ODI-Tech?

The FDA product code for ODI-Tech is MUD.

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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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