iClean 病毒傳送系統 (VTM-RT 套件)
K 號：K212856 · 2022-08-18
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決定日期2022-08-18
產品代碼JSM
諮詢委員會MI
(請提供完整的描述文本，以便進行翻譯。)
決定相當於
器材摘要
iClean Viral Transport System (VTM-RT kit) is the device name listed in this FDA 510(k) record. The listed applicant is Huachenyang (Shenzhen) Technology Co. , Ltd.. It received FDA 510(k) clearance on 2022-08-18 under 510(k) number K212856. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the iClean Viral Transport System (VTM-RT kit)?
iClean Viral Transport System (VTM-RT kit) is a medical device that received FDA 510(k) clearance on 2022-08-18. The listed applicant is Huachenyang (Shenzhen) Technology Co. , Ltd.. The 510(k) number is K212856.
When did iClean Viral Transport System (VTM-RT kit) receive FDA 510(k) clearance?
iClean Viral Transport System (VTM-RT kit) received FDA 510(k) clearance on 2022-08-18, under 510(k) number K212856.
Who is the listed applicant for iClean Viral Transport System (VTM-RT kit)?
The FDA 510(k) record lists Huachenyang (Shenzhen) Technology Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iClean Viral Transport System (VTM-RT kit)?
The FDA product code for iClean Viral Transport System (VTM-RT kit) is JSM.
相關臨床試驗
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相關器械（代碼：JSM）
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。
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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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