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FDA 510(k)

OdneClean

K-Number: K233844 · 2024-08-08

ApplicantOdne AG
Decision Date2024-08-08
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OdneClean is a medical device manufactured by Odne AG. It received FDA 510(k) clearance on 2024-08-08 under approval number K233844. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OdneClean?

OdneClean is a medical device that received FDA 510(k) clearance on 2024-08-08. It is manufactured by Odne AG. The 510(k) number is K233844.

When was OdneClean approved by the FDA?

OdneClean received FDA 510(k) clearance on 2024-08-08, under approval number K233844.

What company makes OdneClean?

OdneClean is manufactured by Odne AG.

What is the FDA product code for OdneClean?

The FDA product code for OdneClean is ELC.

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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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