AViTA脉搏血氧儀 (SP61)
K 號：K252448 · 2026-02-27
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器材摘要
AViTA Pulse Oximeter (SP61) is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2026-02-27 under 510(k) number K252448. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the AViTA Pulse Oximeter (SP61)?
AViTA Pulse Oximeter (SP61) is a medical device that received FDA 510(k) clearance on 2026-02-27. The listed applicant is Avita Corporation. The 510(k) number is K252448.
When did AViTA Pulse Oximeter (SP61) receive FDA 510(k) clearance?
AViTA Pulse Oximeter (SP61) received FDA 510(k) clearance on 2026-02-27, under 510(k) number K252448.
Who is the listed applicant for AViTA Pulse Oximeter (SP61)?
The FDA 510(k) record lists Avita Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AViTA Pulse Oximeter (SP61)?
The FDA product code for AViTA Pulse Oximeter (SP61) is DQA.
相關臨床試驗
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其他以 Avita Corporation 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：DQA）
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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