FDA 510(k)

手環式電子血壓計

K 號：K193386 · 2021-01-27

申請人Shenzhen Changkun Technology Co., Ltd.

決定日期2021-01-27

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Wrist Electronic Sphygmomanometer is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-27 under 510(k) number K193386. 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 Electronic Sphygmomanometer?

Wrist Electronic Sphygmomanometer is a medical device that received FDA 510(k) clearance on 2021-01-27. The listed applicant is Shenzhen Changkun Technology Co., Ltd.. The 510(k) number is K193386.

When did Wrist Electronic Sphygmomanometer receive FDA 510(k) clearance?

Wrist Electronic Sphygmomanometer received FDA 510(k) clearance on 2021-01-27, under 510(k) number K193386.

Who is the listed applicant for Wrist Electronic Sphygmomanometer?

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

What is the FDA product code for Wrist Electronic Sphygmomanometer?

The FDA product code for Wrist Electronic Sphygmomanometer is DXN.

其他以 Shenzhen Changkun 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。

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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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