氧穿戴
K 號：K233827 · 2024-08-28
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器材摘要
OxiWear is the device name listed in this FDA 510(k) record. The listed applicant is Oxiwear, Inc.. It received FDA 510(k) clearance on 2024-08-28 under 510(k) number K233827. 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 OxiWear?
OxiWear is a medical device that received FDA 510(k) clearance on 2024-08-28. The listed applicant is Oxiwear, Inc.. The 510(k) number is K233827.
When did OxiWear receive FDA 510(k) clearance?
OxiWear received FDA 510(k) clearance on 2024-08-28, under 510(k) number K233827.
Who is the listed applicant for OxiWear?
The FDA 510(k) record lists Oxiwear, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OxiWear?
The FDA product code for OxiWear 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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