OdneClean
K 號：K233844 · 2024-08-08
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器材摘要
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.
常見問題
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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相關器械（代碼：ELC）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
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