i-Sil
K 號：K161774 · 2016-09-30
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器材摘要
i-Sil is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K161774. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the i-Sil?
i-Sil is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Spident Co., Ltd.. The 510(k) number is K161774.
When did i-Sil receive FDA 510(k) clearance?
i-Sil received FDA 510(k) clearance on 2016-09-30, under 510(k) number K161774.
Who is the listed applicant for i-Sil?
FDA 510(k) 記錄將 Spident 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 i-Sil?
The FDA product code for i-Sil is ELW.
其他以 Spident Co., Ltd. 為申請人之記錄
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：ELW）
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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