FDA 510(k)

Transtek 血壓監測器；Welch Allyn 901123 電子血壓設備

K 號：K181832 · 2019-04-09

申請人Guangdong Transtek Medical Electronics Co., Ltd.

決定日期2019-04-09

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-04-09 under 510(k) number K181832. 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 Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is a medical device that received FDA 510(k) clearance on 2019-04-09. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K181832.

When did Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device receive FDA 510(k) clearance?

Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device received FDA 510(k) clearance on 2019-04-09, under 510(k) number K181832.

Who is the listed applicant for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

The FDA 510(k) record lists Guangdong Transtek Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device?

The FDA product code for Transtek Blood Pressure Monitor; Welch Allyn 901123 Digital Blood Pressure Device is DXN.

其他以 Guangdong Transtek Medical Electronics Co., Ltd. 為申請人之記錄

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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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