FDA 510(k)

臨床自動血壓監測器（DBP-20,DBP-20i）

K 號：K251307 · 2026-01-12

申請人Shenzhen Hingmed Medical Instrument Co., Ltd.

決定日期2026-01-12

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hingmed Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K251307. 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 Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)?

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Shenzhen Hingmed Medical Instrument Co., Ltd.. The 510(k) number is K251307.

When did Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) receive FDA 510(k) clearance?

Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) received FDA 510(k) clearance on 2026-01-12, under 510(k) number K251307.

Who is the listed applicant for Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)?

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

What is the FDA product code for Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)?

The FDA product code for Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) is DXN.

其他以 Shenzhen Hingmed Medical Instrument 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。

K251581穿戴式行動血壓監測器（WBP-02A）K231984臨床自動血壓監測器（DBP-01P,DBP-01HP）

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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