FDA 510(k)

上臂式自动血压计 BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312

K号: K172896 · 2018-01-26

申请人Shenzhen Jiacom Technology CO ., Ltd.

决定日期2018-01-26

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

Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jiacom Technology CO ., Ltd.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K172896. 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 Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312?

Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is Shenzhen Jiacom Technology CO ., Ltd.. The 510(k) number is K172896.

When did Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 receive FDA 510(k) clearance?

Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 received FDA 510(k) clearance on 2018-01-26, under 510(k) number K172896.

Who is the listed applicant for Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312?

The FDA 510(k) record lists Shenzhen Jiacom Technology CO ., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312?

The FDA product code for Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 is DXN.

列明Shenzhen Jiacom Technology 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。

K172874红外体温计 K172894红外体温计 K172972腕式自动血压计

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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