Rafugen DBM
K 號:K180121 · 2018-04-11
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器材摘要
Rafugen DBM is the device name listed in this FDA 510(k) record. The listed applicant is Cellumed Co., Ltd.. It received FDA 510(k) clearance on 2018-04-11 under 510(k) number K180121. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Rafugen DBM?
Rafugen DBM is a medical device that received FDA 510(k) clearance on 2018-04-11. The listed applicant is Cellumed Co., Ltd.. The 510(k) number is K180121.
When did Rafugen DBM receive FDA 510(k) clearance?
Rafugen DBM received FDA 510(k) clearance on 2018-04-11, under 510(k) number K180121.
Who is the listed applicant for Rafugen DBM?
The FDA 510(k) record lists Cellumed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Rafugen DBM?
The FDA product code for Rafugen DBM is MQV.
相關臨床試驗
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相關器械(代碼:MQV)
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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