思博特X1
K 號：K220072 · 2023-06-18
廣告
決定日期2023-06-18
產品代碼HAW
諮詢委員會NE
(請提供完整的英文描述，以便進行翻譯。)
決定相當於
器材摘要
Sinobot X1 is the device name listed in this FDA 510(k) record. The listed applicant is Sinovation (Beijing) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-18 under 510(k) number K220072. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sinobot X1?
Sinobot X1 is a medical device that received FDA 510(k) clearance on 2023-06-18. The listed applicant is Sinovation (Beijing) Medical Technology Co., Ltd.. The 510(k) number is K220072.
When did Sinobot X1 receive FDA 510(k) clearance?
Sinobot X1 received FDA 510(k) clearance on 2023-06-18, under 510(k) number K220072.
Who is the listed applicant for Sinobot X1?
The FDA 510(k) record lists Sinovation (Beijing) Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sinobot X1?
The FDA product code for Sinobot X1 is HAW.
相關臨床試驗
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相關器械（代碼：HAW）
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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