生物-MEM Ti加強膠膜
K 號：K210797 · 2022-08-18
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器材摘要
Bio-MEM Ti Reinforced Membrane is the device name listed in this FDA 510(k) record. The listed applicant is B&Medi Co., Ltd.. It received FDA 510(k) clearance on 2022-08-18 under 510(k) number K210797. The device is classified under product code NPK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Bio-MEM Ti Reinforced Membrane?
Bio-MEM Ti Reinforced Membrane is a medical device that received FDA 510(k) clearance on 2022-08-18. The listed applicant is B&Medi Co., Ltd.. The 510(k) number is K210797.
When did Bio-MEM Ti Reinforced Membrane receive FDA 510(k) clearance?
Bio-MEM Ti Reinforced Membrane received FDA 510(k) clearance on 2022-08-18, under 510(k) number K210797.
Who is the listed applicant for Bio-MEM Ti Reinforced Membrane?
The FDA 510(k) record lists B&Medi Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bio-MEM Ti Reinforced Membrane?
The FDA product code for Bio-MEM Ti Reinforced Membrane is NPK.
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相關器械（代碼：NPK）
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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