斯匹羅班克氧氣
K 號：K230501 · 2023-12-15
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器材摘要
Spirobank Oxi is the device name listed in this FDA 510(k) record. The listed applicant is Mir Medical International Research USA. It received FDA 510(k) clearance on 2023-12-15 under 510(k) number K230501. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Spirobank Oxi?
Spirobank Oxi is a medical device that received FDA 510(k) clearance on 2023-12-15. The listed applicant is Mir Medical International Research USA. The 510(k) number is K230501.
When did Spirobank Oxi receive FDA 510(k) clearance?
Spirobank Oxi received FDA 510(k) clearance on 2023-12-15, under 510(k) number K230501.
Who is the listed applicant for Spirobank Oxi?
The FDA 510(k) record lists Mir Medical International Research USA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Spirobank Oxi?
The FDA product code for Spirobank Oxi is BZG.
相關臨床試驗
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相關器械（代碼：BZG）
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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