S-Patch (S-Patch ExL)
K 號：K233906 · 2024-02-16
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器材摘要
S-Patch (S-Patch ExL) is the device name listed in this FDA 510(k) record. The listed applicant is Wellysis Corp.. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K233906. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the S-Patch (S-Patch ExL)?
S-Patch (S-Patch ExL) is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Wellysis Corp.. The 510(k) number is K233906.
When did S-Patch (S-Patch ExL) receive FDA 510(k) clearance?
S-Patch (S-Patch ExL) received FDA 510(k) clearance on 2024-02-16, under 510(k) number K233906.
Who is the listed applicant for S-Patch (S-Patch ExL)?
The FDA 510(k) record lists Wellysis Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for S-Patch (S-Patch ExL)?
The FDA product code for S-Patch (S-Patch ExL) is DSH.
相關臨床試驗
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其他以 Wellysis Corp. 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：DSH）
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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