RA-T59 腕式血壓監測器
K 號：K212312 · 2022-01-27
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器材摘要
RA-T59 Wrist blood pressure monitor is the device name listed in this FDA 510(k) record. The listed applicant is Lotusnine Medical Limited. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K212312. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the RA-T59 Wrist blood pressure monitor?
RA-T59 Wrist blood pressure monitor is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Lotusnine Medical Limited. The 510(k) number is K212312.
When did RA-T59 Wrist blood pressure monitor receive FDA 510(k) clearance?
RA-T59 Wrist blood pressure monitor received FDA 510(k) clearance on 2022-01-27, under 510(k) number K212312.
Who is the listed applicant for RA-T59 Wrist blood pressure monitor?
The FDA 510(k) record lists Lotusnine Medical Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RA-T59 Wrist blood pressure monitor?
The FDA product code for RA-T59 Wrist blood pressure monitor is DXN.
相關臨床試驗
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相關器械（代碼：DXN）
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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