OxSAT 100
K 號:K191574 · 2020-04-09
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器材摘要
OxSAT 100 is the device name listed in this FDA 510(k) record. The listed applicant is S.L.P. , Ltd.. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K191574. 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 OxSAT 100?
OxSAT 100 is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is S.L.P. , Ltd.. The 510(k) number is K191574.
When did OxSAT 100 receive FDA 510(k) clearance?
OxSAT 100 received FDA 510(k) clearance on 2020-04-09, under 510(k) number K191574.
Who is the listed applicant for OxSAT 100?
The FDA 510(k) record lists S.L.P. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OxSAT 100?
The FDA product code for OxSAT 100 is DQA.
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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
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