BB-613 腕式血氧計
K 號：K181006 · 2018-09-21
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器材摘要
BB-613 Watch Oximeter is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Beat Technologies , Ltd.. It received FDA 510(k) clearance on 2018-09-21 under 510(k) number K181006. 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 BB-613 Watch Oximeter?
BB-613 Watch Oximeter is a medical device that received FDA 510(k) clearance on 2018-09-21. The listed applicant is Bio-Beat Technologies , Ltd.. The 510(k) number is K181006.
When did BB-613 Watch Oximeter receive FDA 510(k) clearance?
BB-613 Watch Oximeter received FDA 510(k) clearance on 2018-09-21, under 510(k) number K181006.
Who is the listed applicant for BB-613 Watch Oximeter?
The FDA 510(k) record lists Bio-Beat Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BB-613 Watch Oximeter?
The FDA product code for BB-613 Watch Oximeter 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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