FDA 510(k)

血壓監測器

K 號：K223374 · 2023-06-30

申請人Guangdong Transtek Medical Electronics Co., Ltd.

決定日期2023-06-30

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Blood Pressure Monitor 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 2023-06-30 under 510(k) number K223374. 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 Blood Pressure Monitor?

Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2023-06-30. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K223374.

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

Blood Pressure Monitor received FDA 510(k) clearance on 2023-06-30, under 510(k) number K223374.

Who is the listed applicant for Blood Pressure Monitor?

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 Blood Pressure Monitor?

The FDA product code for Blood Pressure Monitor is DXN.

其他以 Guangdong Transtek Medical Electronics 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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官方來源

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