FDA 510(k)

自动臂式电子血压监测仪

K号: K210435 · 2021-05-12

申请人Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.

决定日期2021-05-12

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 Arm Electronic Blood Pressure Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-05-12 under 510(k) number K210435. 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 Arm Electronic Blood Pressure Monitor?

Automatic Arm Electronic Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2021-05-12. The listed applicant is Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. The 510(k) number is K210435.

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

Automatic Arm Electronic Blood Pressure Monitor received FDA 510(k) clearance on 2021-05-12, under 510(k) number K210435.

Who is the listed applicant for Automatic Arm Electronic Blood Pressure Monitor?

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

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

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

列明Shenzhen Lepu Intelligent Medical Equipment 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。

K202776指尖脉搏血氧仪 K202687红外额温计，型号LFR30B，LFR50，LFR60

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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