ORskin 藍
K 號：K232858 · 2024-05-01
廣告
器材摘要
ORskin Blue is the device name listed in this FDA 510(k) record. The listed applicant is Megabay S.A.. It received FDA 510(k) clearance on 2024-05-01 under 510(k) number K232858. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常見問題
What is the ORskin Blue?
ORskin Blue is a medical device that received FDA 510(k) clearance on 2024-05-01. The listed applicant is Megabay S.A.. The 510(k) number is K232858.
When did ORskin Blue receive FDA 510(k) clearance?
ORskin Blue received FDA 510(k) clearance on 2024-05-01, under 510(k) number K232858.
Who is the listed applicant for ORskin Blue?
The FDA 510(k) record lists Megabay S.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ORskin Blue?
The FDA product code for ORskin Blue is GEX. This falls under the Gastroenterology category.
相關臨床試驗
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：GEX）
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。
K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro 系列Fotona D.O.O.K241973SmartIPL_NI 系統Lumenis Be, Ltd.K261047牙科二極雷射設備（雷射筆）Guilin Kevin Peter Technology Co., Ltd.K261817二極雷射治療系統（PZ-BDT67-01，PZ-BDT67-02）Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED治療設備（QLXY-01）Beijing Nubway S&T 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