AI100 with Shonit
K 號：K221309 · 2023-09-19
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器材摘要
AI100 with Shonit is the device name listed in this FDA 510(k) record. The listed applicant is Sigtuple Technologies Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-09-19 under 510(k) number K221309. The device is classified under product code JOY. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AI100 with Shonit?
AI100 with Shonit is a medical device that received FDA 510(k) clearance on 2023-09-19. The listed applicant is Sigtuple Technologies Pvt. , Ltd.. The 510(k) number is K221309.
When did AI100 with Shonit receive FDA 510(k) clearance?
AI100 with Shonit received FDA 510(k) clearance on 2023-09-19, under 510(k) number K221309.
Who is the listed applicant for AI100 with Shonit?
The FDA 510(k) record lists Sigtuple Technologies Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AI100 with Shonit?
The FDA product code for AI100 with Shonit is JOY.
相關臨床試驗
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相關器械（代碼：JOY）
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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