SICAGE™ 系統
K 號：K170475 · 2017-05-05
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器材摘要
SICAGE™ System is the device name listed in this FDA 510(k) record. The listed applicant is Sicage, LLC. It received FDA 510(k) clearance on 2017-05-05 under 510(k) number K170475. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SICAGE™ System?
SICAGE™ System is a medical device that received FDA 510(k) clearance on 2017-05-05. The listed applicant is Sicage, LLC. The 510(k) number is K170475.
When did SICAGE™ System receive FDA 510(k) clearance?
SICAGE™ System received FDA 510(k) clearance on 2017-05-05, under 510(k) number K170475.
Who is the listed applicant for SICAGE™ System?
The FDA 510(k) record lists Sicage, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SICAGE™ System?
The FDA product code for SICAGE™ System is OUR.
相關臨床試驗
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相關器械（代碼：OUR）
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。
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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