FDA 510(k)

腕式电子血压计（U16H、U16L、U16P、U16W、U19M、U19R、U19S和U19T）

K号: K254048 · 2026-05-14

决定日期2026-05-14

产品代码DXN

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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.

列明Shenzhen Urion Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260273自动电子血压计（U90B系列型号包括（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上臂电子血压计（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）和U83Z系列（包括U83Z、U80Z、U81Z、U82Z、U85Z、U86Z和U87Z））K241007上臂电子血压计（U86E和TelliBP01）K200802红外体温计 K160019U80系列上臂式电子血压计

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