NuEra Tight 電波模型 OptiStream
K 號：K230755 · 2023-10-30
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器材摘要
NuEra Tight RF Model OptiStream is the device name listed in this FDA 510(k) record. The listed applicant is Bios S.R.L.. It received FDA 510(k) clearance on 2023-10-30 under 510(k) number K230755. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the NuEra Tight RF Model OptiStream?
NuEra Tight RF Model OptiStream is a medical device that received FDA 510(k) clearance on 2023-10-30. The listed applicant is Bios S.R.L.. The 510(k) number is K230755.
When did NuEra Tight RF Model OptiStream receive FDA 510(k) clearance?
NuEra Tight RF Model OptiStream received FDA 510(k) clearance on 2023-10-30, under 510(k) number K230755.
Who is the listed applicant for NuEra Tight RF Model OptiStream?
The FDA 510(k) record lists Bios S.R.L. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for NuEra Tight RF Model OptiStream?
The FDA product code for NuEra Tight RF Model OptiStream is PBX.
相關臨床試驗
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其他以 Bios S.R.L. 為申請人之記錄
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：PBX）
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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