FDA 510(k)

全自动（NIBP）血压计

K号: K153214 · 2016-01-07

决定日期2016-01-07

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 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 2016-01-07 under 510(k) number K153214. 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?

Full Automatic (NIBP) Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2016-01-07. The listed applicant is Health & Life Co., Ltd.. The 510(k) number is K153214.

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

Full Automatic (NIBP) Blood Pressure Monitor received FDA 510(k) clearance on 2016-01-07, under 510(k) number K153214.

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

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?

The FDA product code for Full Automatic (NIBP) Blood Pressure Monitor 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 K190134全自动（NIBP）血压计-HL158TB

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。