蘇洛培南SPM 2 µg
K 號：K251879 · 2025-08-12
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器材摘要
Sulopenem SPM 2 µg is the device name listed in this FDA 510(k) record. The listed applicant is Liofilchem. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K251879. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Sulopenem SPM 2 µg?
Sulopenem SPM 2 µg is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Liofilchem. The 510(k) number is K251879.
When did Sulopenem SPM 2 µg receive FDA 510(k) clearance?
Sulopenem SPM 2 µg received FDA 510(k) clearance on 2025-08-12, under 510(k) number K251879.
Who is the listed applicant for Sulopenem SPM 2 µg?
The FDA 510(k) record lists Liofilchem as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sulopenem SPM 2 µg?
The FDA product code for Sulopenem SPM 2 µg is JTN.
相關臨床試驗
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相關器械（代碼：JTN）
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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