GEMS-H
K 號：K213452 · 2022-04-21
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器材摘要
GEMS-H is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Electronics Co., Ltd.. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213452. The device is classified under product code PHL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the GEMS-H?
GEMS-H is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K213452.
When did GEMS-H receive FDA 510(k) clearance?
GEMS-H received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213452.
Who is the listed applicant for GEMS-H?
FDA 510(k) 記錄將三星電子有限公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for GEMS-H?
The FDA product code for GEMS-H is PHL.
其他以 Samsung Electronics 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：PHL）
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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