FDA 510(k)

自動手臂藍牙血壓監測器

K 號：K161846 · 2016-10-24

決定日期2016-10-24

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Automatic Arm Bluetooth Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Truly Instrument Limited. It received FDA 510(k) clearance on 2016-10-24 under 510(k) number K161846. 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 Automatic Arm Bluetooth Blood Pressure Monitor?

Automatic Arm Bluetooth Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-10-24. The listed applicant is Truly Instrument Limited. The 510(k) number is K161846.

When did Automatic Arm Bluetooth Blood Pressure Monitor receive FDA 510(k) clearance?

Automatic Arm Bluetooth Blood Pressure Monitor received FDA 510(k) clearance on 2016-10-24, under 510(k) number K161846.

Who is the listed applicant for Automatic Arm Bluetooth Blood Pressure Monitor?

The FDA 510(k) record lists Truly Instrument Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automatic Arm Bluetooth Blood Pressure Monitor?

The FDA product code for Automatic Arm Bluetooth Blood Pressure Monitor is DXN.

其他以 Truly Instrument Limited 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。

K220276紅外線體溫計 TET-351 K192023手臂血壓監測器

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

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。