醫療設備規範文本翻譯(zh-TW): NERBRIDGE
K 號:K152967 · 2016-06-22
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器材摘要
NERBRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Toyobo Co., Ltd.. It received FDA 510(k) clearance on 2016-06-22 under 510(k) number K152967. The device is classified under product code JXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the NERBRIDGE?
NERBRIDGE is a medical device that received FDA 510(k) clearance on 2016-06-22. The listed applicant is Toyobo Co., Ltd.. The 510(k) number is K152967.
When did NERBRIDGE receive FDA 510(k) clearance?
NERBRIDGE received FDA 510(k) clearance on 2016-06-22, under 510(k) number K152967.
Who is the listed applicant for NERBRIDGE?
The FDA 510(k) record lists Toyobo Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NERBRIDGE?
The FDA product code for NERBRIDGE is JXI.
相關臨床試驗
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。
相關器械(代碼:JXI)
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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