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FDA 510(k)

Transtek 手腕式血壓監測器

K 號：K202599 · 2020-12-06

申請人Guangdong Transtek Medical Electronics Co., Ltd.
決定日期2020-12-06
產品代碼DXN
諮詢委員會履歷
決定相當於

器材摘要

Transtek Wrist 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 2020-12-06 under 510(k) number K202599. 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 Wrist Blood Pressure Monitor?

Transtek Wrist Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2020-12-06. The listed applicant is Guangdong Transtek Medical Electronics Co., Ltd.. The 510(k) number is K202599.

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

Transtek Wrist Blood Pressure Monitor received FDA 510(k) clearance on 2020-12-06, under 510(k) number K202599.

Who is the listed applicant for Transtek Wrist 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 Transtek Wrist Blood Pressure Monitor?

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

相關臨床試驗

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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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