0909FCB，1212FCA
K 號：K212753 · 2021-10-18
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器材摘要
0909FCB, 1212FCA is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2021-10-18 under 510(k) number K212753. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the 0909FCB, 1212FCA?
0909FCB, 1212FCA is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K212753.
When did 0909FCB, 1212FCA receive FDA 510(k) clearance?
0909FCB, 1212FCA received FDA 510(k) clearance on 2021-10-18, under 510(k) number K212753.
Who is the listed applicant for 0909FCB, 1212FCA?
FDA 510(k) 記錄將 Rayence Co., Ltd. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for 0909FCB, 1212FCA?
The FDA product code for 0909FCB, 1212FCA is MQB.
其他以 Rayence Co., Ltd. 為申請人之記錄
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相關器械（代碼：MQB）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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