氧氣濃度監測器 1000
K 號：K163382 · 2017-05-09
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器材摘要
Oxitone 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Oxitone Medical , Ltd.. It received FDA 510(k) clearance on 2017-05-09 under 510(k) number K163382. 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 Oxitone 1000?
Oxitone 1000 is a medical device that received FDA 510(k) clearance on 2017-05-09. The listed applicant is Oxitone Medical , Ltd.. The 510(k) number is K163382.
When did Oxitone 1000 receive FDA 510(k) clearance?
Oxitone 1000 received FDA 510(k) clearance on 2017-05-09, under 510(k) number K163382.
Who is the listed applicant for Oxitone 1000?
The FDA 510(k) record lists Oxitone Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Oxitone 1000?
The FDA product code for Oxitone 1000 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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