FDA 510(k)

手環型自動血壓監測器

K 號：K172972 · 2018-03-02

申請人Shenzhen Jiacom Technology CO ., Ltd.

決定日期2018-03-02

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Wrist Type Automatic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jiacom Technology CO ., Ltd.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K172972. 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 Wrist Type Automatic Blood Pressure Monitor?

Wrist Type Automatic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Shenzhen Jiacom Technology CO ., Ltd.. The 510(k) number is K172972.

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

Wrist Type Automatic Blood Pressure Monitor received FDA 510(k) clearance on 2018-03-02, under 510(k) number K172972.

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

The FDA 510(k) record lists Shenzhen Jiacom Technology CO ., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Shenzhen Jiacom 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。

K172874紅外線體溫計 K172894紅外線體溫計 K172896手臂型自動血壓監測器 BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312

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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