FDA 510(k)

手錶式電子血壓監測器（U16H、U16L、U16P、U16W、U19M、U19R、U19S、U19T）

K 號：K254048 · 2026-05-14

決定日期2026-05-14

產品代碼DXN

諮詢委員會履歷

決定相當於

器材摘要

Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Urion Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K254048. 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 Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)?

Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Shenzhen Urion Technology Co., Ltd.. The 510(k) number is K254048.

When did Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) receive FDA 510(k) clearance?

Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) received FDA 510(k) clearance on 2026-05-14, under 510(k) number K254048.

Who is the listed applicant for Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)?

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

What is the FDA product code for Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)?

The FDA product code for Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) is DXN.

其他以 Shenzhen Urion 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。

K260273自動電子血壓監測儀 (U90B 系列型號包括 (U90B, U90B Pro, U90B Plus, U90B Ultra, U90C, U90C Pro, U90C Plus, U90C Ultra))K250046空气压缩腿部按摩器（UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617）K243115上臂電子血壓計（U87Y系列（包括U80Y、U81Y、U82Y、U83Y、U86Y、U80N、U81NH），U86E系列（包括U82E、U80E、U80EH、U81E、U83E、U85E、U80L、U87E），U81X系列（包括U81X、U80X、U82X、U83X、U81D、U82D、U83D、U81RH、U82RH）以及U83Z系列（包括U83Z、U80Z、U81Z、U82Z、U85Z、U86Z和U87Z））K241007上臂電子血壓計（U86E 和 TelliBP01）K200802紅外線體溫計 K160019U80系列上臂電子血壓監測器

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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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