Decision Date2024-08-08
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OdneClean is the device name listed in this FDA 510(k) record. The listed applicant is Odne AG. It received FDA 510(k) clearance on 2024-08-08 under 510(k) 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. The listed applicant is Odne AG. The 510(k) number is K233844.
When did OdneClean receive FDA 510(k) clearance?
OdneClean received FDA 510(k) clearance on 2024-08-08, under 510(k) number K233844.
Who is the listed applicant for OdneClean?
The FDA 510(k) record lists Odne AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OdneClean?
The FDA product code for OdneClean is ELC.
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Official Source
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