GM85
K 號：K242651 · 2024-10-01
廣告
器材摘要
GM85 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 2024-10-01 under 510(k) number K242651. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the GM85?
GM85 is a medical device that received FDA 510(k) clearance on 2024-10-01. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K242651.
When did GM85 receive FDA 510(k) clearance?
GM85 received FDA 510(k) clearance on 2024-10-01, under 510(k) number K242651.
Who is the listed applicant for GM85?
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 GM85?
The FDA product code for GM85 is IZL.
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：IZL）
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。
K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058攜帶式DR影像系統Shantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO移動X光系統（型號：RAYMO）DRGEM CorporationK253185Lux HD 檢測器，DRX-LC 檢測器，DRX-Revolution 移動 X 光系統Carestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.
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。
廣告