恩斯美爾
K 號：K222619 · 2023-03-16
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器材摘要
Ensmile is the device name listed in this FDA 510(k) record. The listed applicant is Ensmile Pvt, Ltd.. It received FDA 510(k) clearance on 2023-03-16 under 510(k) number K222619. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ensmile?
Ensmile is a medical device that received FDA 510(k) clearance on 2023-03-16. The listed applicant is Ensmile Pvt, Ltd.. The 510(k) number is K222619.
When did Ensmile receive FDA 510(k) clearance?
Ensmile received FDA 510(k) clearance on 2023-03-16, under 510(k) number K222619.
Who is the listed applicant for Ensmile?
The FDA 510(k) record lists Ensmile Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ensmile?
The FDA product code for Ensmile is NXC.
相關臨床試驗
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相關器械（代碼：NXC）
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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