BioProtect 機械植入體™ 系統
K 號：K222972 · 2023-08-25
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器材摘要
BioProtect Balloon Implant™ System is the device name listed in this FDA 510(k) record. The listed applicant is Bioprotect, Ltd.. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K222972. The device is classified under product code OVB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the BioProtect Balloon Implant™ System?
BioProtect Balloon Implant™ System is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Bioprotect, Ltd.. The 510(k) number is K222972.
When did BioProtect Balloon Implant™ System receive FDA 510(k) clearance?
BioProtect Balloon Implant™ System received FDA 510(k) clearance on 2023-08-25, under 510(k) number K222972.
Who is the listed applicant for BioProtect Balloon Implant™ System?
The FDA 510(k) record lists Bioprotect, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BioProtect Balloon Implant™ System?
The FDA product code for BioProtect Balloon Implant™ System is OVB.
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相關器械（代碼：OVB）
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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