BTL-094
K 號：K221865 · 2023-04-14
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器材摘要
BTL-094 is the device name listed in this FDA 510(k) record. The listed applicant is BTL Industries, Inc.. It received FDA 510(k) clearance on 2023-04-14 under 510(k) number K221865. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BTL-094?
BTL-094 is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is BTL Industries, Inc.. The 510(k) number is K221865.
When did BTL-094 receive FDA 510(k) clearance?
BTL-094 received FDA 510(k) clearance on 2023-04-14, under 510(k) number K221865.
Who is the listed applicant for BTL-094?
FDA 510(k) 記錄將 BTL Industries, Inc. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for BTL-094?
The FDA product code for BTL-094 is ISA.
其他以 BTL Industries, Inc. 為申請人之記錄
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相關器械（代碼：ISA）
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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