MSCB-001
K 號：K152274 · 2016-03-25
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器材摘要
MSCB-001 is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K152274. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the MSCB-001?
MSCB-001 is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is GC America, Inc.. The 510(k) number is K152274.
When did MSCB-001 receive FDA 510(k) clearance?
MSCB-001 received FDA 510(k) clearance on 2016-03-25, under 510(k) number K152274.
Who is the listed applicant for MSCB-001?
FDA 510(k) 記錄將 GC America, 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 MSCB-001?
The FDA product code for MSCB-001 is EIH.
其他以 GC America, Inc. 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：EIH）
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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