FDA 510(k)

YUWELL电子血压计

K号: K221372 · 2022-10-17

申请人Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

决定日期2022-10-17

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

YUWELL Electronic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. It received FDA 510(k) clearance on 2022-10-17 under 510(k) number K221372. 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 YUWELL Electronic Blood Pressure Monitor?

YUWELL Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2022-10-17. The listed applicant is Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. The 510(k) number is K221372.

When did YUWELL Electronic Blood Pressure Monitor receive FDA 510(k) clearance?

YUWELL Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2022-10-17, under 510(k) number K221372.

Who is the listed applicant for YUWELL Electronic Blood Pressure Monitor?

FDA 510(k)记录将江苏宇悦医疗设备供应有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for YUWELL Electronic Blood Pressure Monitor?

The FDA product code for YUWELL Electronic Blood Pressure Monitor is DXN.

列明Jiangsu Yuyue Medical Equipment & Supply 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。

K261571手动轮椅（H008，PCK7）K252779优威尔® 电子血压计（YE630CR）K253228尤威尔® 电子血压计（YE650AR）K252805优威尔®指夹式脉搏血氧仪（YX105，YX106，YX110，YX310）K242736便携式制氧机（Spirit-3）K250878优威尔® 红外耳温枪（YHT100）；优威尔® 红外耳温枪（YHT107）

查看所有 13 个设备 →

相关器械（代码：DXN）

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。

K261929上臂血压计（BP7155D）OMRON Healthcare, Inc.K254000快乐健康血压计Happy Health, Inc.K262658自动数字血压计（LD-526）Honsun (Nantong) Co., Ltd.K261394臂式全自动数字血压计（DBP-6186 Plus，DBP-6286B Plus，DBP-61E3 Plus，DBP-61E2 Plus，DBP-62E3B Plus，DBP-62E2B Plus）JOYTECH Healthcare Co., Ltd.K253425臂式全自动数字血压计（DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P）Joytech Healthcare Co. , Ltd.K261061BP Go（BPP-855）Wellvii, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。