牙科二極雷射
K 號：K214008 · 2022-05-10
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器材摘要
Dental diode laser is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Soga Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-10 under 510(k) number K214008. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Dental diode laser?
Dental diode laser is a medical device that received FDA 510(k) clearance on 2022-05-10. The listed applicant is Shenzhen Soga Technology Co., Ltd.. The 510(k) number is K214008.
When did Dental diode laser receive FDA 510(k) clearance?
Dental diode laser received FDA 510(k) clearance on 2022-05-10, under 510(k) number K214008.
Who is the listed applicant for Dental diode laser?
The FDA 510(k) record lists Shenzhen Soga Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dental diode laser?
The FDA product code for Dental diode laser is NVK.
相關臨床試驗
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其他以 Shenzhen Soga Technology 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：NVK）
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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