Purema H 血漿濃縮器 - 小兒用
K 號：K243920 · 2025-09-19
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器材摘要
Purema H Hemoconcentrator - Pediatric is the device name listed in this FDA 510(k) record. The listed applicant is Medica USA, Inc.. It received FDA 510(k) clearance on 2025-09-19 under 510(k) number K243920. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Purema H Hemoconcentrator - Pediatric?
Purema H Hemoconcentrator - Pediatric is a medical device that received FDA 510(k) clearance on 2025-09-19. The listed applicant is Medica USA, Inc.. The 510(k) number is K243920.
When did Purema H Hemoconcentrator - Pediatric receive FDA 510(k) clearance?
Purema H Hemoconcentrator - Pediatric received FDA 510(k) clearance on 2025-09-19, under 510(k) number K243920.
Who is the listed applicant for Purema H Hemoconcentrator - Pediatric?
The FDA 510(k) record lists Medica USA, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Purema H Hemoconcentrator - Pediatric?
The FDA product code for Purema H Hemoconcentrator - Pediatric is KDI.
相關臨床試驗
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相關器械（代碼：KDI）
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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