FDA 510(k)臂式全自动數字血壓監測儀，腕式全自动數字血壓監測儀
K 號：K212115 · 2022-01-05
決定日期2022-01-05
產品代碼DXN
諮詢委員會履歷
決定相當於
器材摘要
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2022-01-05 under 510(k) number K212115. 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 Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor?
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2022-01-05. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K212115.
When did Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor receive FDA 510(k) clearance?
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2022-01-05, under 510(k) number K212115.
Who is the listed applicant for Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor?
FDA 510(k) 記錄將 Joytech Healthcare Co., Ltd. 列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor?
The FDA product code for Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor is DXN.
相關臨床試驗
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其他以 Joytech Healthcare Co. , Ltd. 為申請人之記錄
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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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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