MINE ALNU（型號：Mine 2.1）
K 號：K213405 · 2022-07-10
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器材摘要
MINE ALNU (Model: Mine 2.1) is the device name listed in this FDA 510(k) record. The listed applicant is Hdt Co., Ltd.. It received FDA 510(k) clearance on 2022-07-10 under 510(k) number K213405. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MINE ALNU (Model: Mine 2.1)?
MINE ALNU (Model: Mine 2.1) is a medical device that received FDA 510(k) clearance on 2022-07-10. The listed applicant is Hdt Co., Ltd.. The 510(k) number is K213405.
When did MINE ALNU (Model: Mine 2.1) receive FDA 510(k) clearance?
MINE ALNU (Model: Mine 2.1) received FDA 510(k) clearance on 2022-07-10, under 510(k) number K213405.
Who is the listed applicant for MINE ALNU (Model: Mine 2.1)?
The FDA 510(k) record lists Hdt Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MINE ALNU (Model: Mine 2.1)?
The FDA product code for MINE ALNU (Model: Mine 2.1) is IZL.
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相關器械（代碼：IZL）
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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