FDA 510(k)

自动血压监测仪型号LD-562U，LD-588U & LD-533U

K号: K170454 · 2017-10-25

决定日期2017-10-25

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

Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K170454. 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 Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U?

Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K170454.

When did Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U receive FDA 510(k) clearance?

Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U received FDA 510(k) clearance on 2017-10-25, under 510(k) number K170454.

Who is the listed applicant for Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U?

FDA 510(k)记录将江苏恒生医疗器械有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U?

The FDA product code for Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U is DXN.

列明Honsun (Nantong) 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。

K262658自动数字血压计（LD-526）K252399便携式制氧机 K260260自动数字血压计（LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569）K251795手腕式自动血压计（LD-735，LD-752，LD-753）K211629红外额温计 LD-FT-100B K192500带听诊器的血压计，水银血压计

查看所有 9 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

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