ReShape 調校管
K 號：K230131 · 2023-02-15
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器材摘要
ReShape Calibration Tubes is the device name listed in this FDA 510(k) record. The listed applicant is Reshape Lifesciences. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K230131. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ReShape Calibration Tubes?
ReShape Calibration Tubes is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Reshape Lifesciences. The 510(k) number is K230131.
When did ReShape Calibration Tubes receive FDA 510(k) clearance?
ReShape Calibration Tubes received FDA 510(k) clearance on 2023-02-15, under 510(k) number K230131.
Who is the listed applicant for ReShape Calibration Tubes?
The FDA 510(k) record lists Reshape Lifesciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ReShape Calibration Tubes?
The FDA product code for ReShape Calibration Tubes is KNT.
相關臨床試驗
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其他以 Reshape Lifesciences 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：KNT）
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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