醫療設備名稱：WERAY 醫療設備規範文本：此設備已通過FDA認證，並獲得510(k)許可證。該設備已提交PMA申請，並在NCT登錄編號為[識別號]的臨床試驗中進行測試。相關文獻的PMID編號為[識別號]。請參考以下網址獲取更多信息：[URL]
K 號：K241963 · 2024-07-30
廣告
器材摘要
WERAY is the device name listed in this FDA 510(k) record. The listed applicant is Picopack Co., Ltd.. It received FDA 510(k) clearance on 2024-07-30 under 510(k) number K241963. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the WERAY?
WERAY is a medical device that received FDA 510(k) clearance on 2024-07-30. The listed applicant is Picopack Co., Ltd.. The 510(k) number is K241963.
When did WERAY receive FDA 510(k) clearance?
WERAY received FDA 510(k) clearance on 2024-07-30, under 510(k) number K241963.
Who is the listed applicant for WERAY?
The FDA 510(k) record lists Picopack Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WERAY?
The FDA product code for WERAY is EHD.
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：EHD）
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。
K260795手持式牙科X光系統（HyperLight-M）Changzhou Sifary Medical Technology Co., Ltd.K260367可攜式牙科X光系統型號 PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110牙科X光單元（AJX200）Guangzhou Ajax Medical Equipment Co., Ltd.K254018攜帶式牙科X光設備（GT-1）Guilin Refine Medical Instrument Co., Ltd.K252909診斷X光設備型號 POCT22Ningbo Runyes Medical Instrument 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