EL27-Compact；无菌EHL-Probes
K 號：K230488 · 2023-08-31
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器材摘要
EL27-Compact; Sterile EHL-Probes is the device name listed in this FDA 510(k) record. The listed applicant is Walz Elektronik GmbH. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K230488. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the EL27-Compact; Sterile EHL-Probes?
EL27-Compact; Sterile EHL-Probes is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Walz Elektronik GmbH. The 510(k) number is K230488.
When did EL27-Compact; Sterile EHL-Probes receive FDA 510(k) clearance?
EL27-Compact; Sterile EHL-Probes received FDA 510(k) clearance on 2023-08-31, under 510(k) number K230488.
Who is the listed applicant for EL27-Compact; Sterile EHL-Probes?
The FDA 510(k) record lists Walz Elektronik GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EL27-Compact; Sterile EHL-Probes?
The FDA product code for EL27-Compact; Sterile EHL-Probes is FFK.
相關臨床試驗
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：FFK）
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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