Fecobionics 粪便電子系統
K 號：K242666 · 2025-02-12
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器材摘要
Fecobionics Anorectal System is the device name listed in this FDA 510(k) record. The listed applicant is Gi Bionics, LLC. It received FDA 510(k) clearance on 2025-02-12 under 510(k) number K242666. The device is classified under product code KLA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Fecobionics Anorectal System?
Fecobionics Anorectal System is a medical device that received FDA 510(k) clearance on 2025-02-12. The listed applicant is Gi Bionics, LLC. The 510(k) number is K242666.
When did Fecobionics Anorectal System receive FDA 510(k) clearance?
Fecobionics Anorectal System received FDA 510(k) clearance on 2025-02-12, under 510(k) number K242666.
Who is the listed applicant for Fecobionics Anorectal System?
The FDA 510(k) record lists Gi Bionics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fecobionics Anorectal System?
The FDA product code for Fecobionics Anorectal System is KLA.
相關臨床試驗
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相關器械（代碼：KLA）
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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