氣球充氣系統
K 號：K232842 · 2024-02-29
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器材摘要
Balloon Inflation System is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Hicren Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-29 under 510(k) number K232842. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Balloon Inflation System?
Balloon Inflation System is a medical device that received FDA 510(k) clearance on 2024-02-29. The listed applicant is Ningbo Hicren Biotechnology Co., Ltd.. The 510(k) number is K232842.
When did Balloon Inflation System receive FDA 510(k) clearance?
Balloon Inflation System received FDA 510(k) clearance on 2024-02-29, under 510(k) number K232842.
Who is the listed applicant for Balloon Inflation System?
The FDA 510(k) record lists Ningbo Hicren Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Balloon Inflation System?
The FDA product code for Balloon Inflation System is NDN.
相關臨床試驗
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相關器械（代碼：NDN）
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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