FDA 510(k)

AGE自動手腕血壓監測儀

K 號：K193628 · 2020-07-12

決定日期2020-07-12

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

AGE Automatic Wrist Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan E-Test Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-07-12 under 510(k) number K193628. 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 AGE Automatic Wrist Blood Pressure Monitor?

AGE Automatic Wrist Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-07-12. The listed applicant is Dongguan E-Test Technology Co., Ltd.. The 510(k) number is K193628.

When did AGE Automatic Wrist Blood Pressure Monitor receive FDA 510(k) clearance?

AGE Automatic Wrist Blood Pressure Monitor received FDA 510(k) clearance on 2020-07-12, under 510(k) number K193628.

Who is the listed applicant for AGE Automatic Wrist Blood Pressure Monitor?

The FDA 510(k) record lists Dongguan E-Test Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGE Automatic Wrist Blood Pressure Monitor?

The FDA product code for AGE Automatic Wrist Blood Pressure Monitor is DXN.

其他以 Dongguan E-Test Technology 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。

K250231自動上臂血壓監測器 (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)K193621數位體溫計-(型號 BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318)K193627自動上臂血壓監測器 K193624自動上臂血壓監測器

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。

K261929上臂血壓監測器（BP7155D）OMRON Healthcare, Inc.K254000快樂健康血壓監測器Happy Health, Inc.K262658自動數位血壓監測器（LD-526）Honsun (Nantong) Co., Ltd.K261394臂式全自動數字血壓計（DBP-6186 Plus、DBP-6286B Plus、DBP-61E3 Plus、DBP-61E2 Plus、DBP-62E3B Plus、DBP-62E2B Plus）JOYTECH Healthcare Co., Ltd.K253425臂式全自动數字血壓監測儀（DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P）Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

官方來源

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