FDA 510(k)

全自动（NIBP）血压计-HL158TB

K号: K190134 · 2019-05-20

决定日期2019-05-20

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

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is the device name listed in this FDA 510(k) record. The listed applicant is Health & Life Co., Ltd.. It received FDA 510(k) clearance on 2019-05-20 under 510(k) number K190134. 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 Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is a medical device that received FDA 510(k) clearance on 2019-05-20. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K190134.

When did Full Automatic (NIBP) Blood Pressure Monitor-HL158TB receive FDA 510(k) clearance?

Full Automatic (NIBP) Blood Pressure Monitor-HL158TB received FDA 510(k) clearance on 2019-05-20, under 510(k) number K190134.

Who is the listed applicant for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

The FDA 510(k) record lists Health & Life Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB?

The FDA product code for Full Automatic (NIBP) Blood Pressure Monitor-HL158TB is DXN.

列明Health & Life 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。

K211744非接触式红外线体温计，型号HL710H K211127全自动（NIBP）血压计，型号HL858DM K200521全自动(NIBP)血压计 K190507全自动（NIBP）血压计 K190133全自动（NIBP）血压计-HL158UB K180240全自动(NIBP)血压计

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。