Q閃脈式Nd:YAG雷射機器（QNHF-01）
K 號：K242943 · 2025-03-03
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器材摘要
Q Switched Nd:YAG Laser machine (QNHF-01) is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Nubway S&T Co., Ltd.. It received FDA 510(k) clearance on 2025-03-03 under 510(k) number K242943. 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 Q Switched Nd:YAG Laser machine (QNHF-01)?
Q Switched Nd:YAG Laser machine (QNHF-01) is a medical device that received FDA 510(k) clearance on 2025-03-03. The listed applicant is Beijing Nubway S&T Co., Ltd.. The 510(k) number is K242943.
When did Q Switched Nd:YAG Laser machine (QNHF-01) receive FDA 510(k) clearance?
Q Switched Nd:YAG Laser machine (QNHF-01) received FDA 510(k) clearance on 2025-03-03, under 510(k) number K242943.
Who is the listed applicant for Q Switched Nd:YAG Laser machine (QNHF-01)?
FDA 510(k) 記錄將北京諾威科技發展有限公司列為申請人。這並不單獨確立設備製造商的身份。
What is the FDA product code for Q Switched Nd:YAG Laser machine (QNHF-01)?
The FDA product code for Q Switched Nd:YAG Laser machine (QNHF-01) 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。
其他以 Beijing Nubway S&T 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：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。
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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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