RedDrop ONE (一)
K 號：K234081 · 2024-03-21
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器材摘要
RedDrop ONE (One) is the device name listed in this FDA 510(k) record. The listed applicant is Reddrop DX. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K234081. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Unknown.
常見問題
What is the RedDrop ONE (One)?
RedDrop ONE (One) is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Reddrop DX. The 510(k) number is K234081.
When did RedDrop ONE (One) receive FDA 510(k) clearance?
RedDrop ONE (One) received FDA 510(k) clearance on 2024-03-21, under 510(k) number K234081.
Who is the listed applicant for RedDrop ONE (One)?
The FDA 510(k) record lists Reddrop DX as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RedDrop ONE (One)?
The FDA product code for RedDrop ONE (One) is FMK.
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相關器械（代碼：FMK）
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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