FDA 510(k)

血压计-型号 2005，2006-2，2006-2B

K号: K201467 · 2020-09-21

决定日期2020-09-21

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

Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B is the device name listed in this FDA 510(k) record. The listed applicant is Bioland Technology, Ltd.. It received FDA 510(k) clearance on 2020-09-21 under 510(k) number K201467. 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 Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B?

Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B is a medical device that received FDA 510(k) clearance on 2020-09-21. The listed applicant is Bioland Technology, Ltd.. The 510(k) number is K201467.

When did Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B receive FDA 510(k) clearance?

Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B received FDA 510(k) clearance on 2020-09-21, under 510(k) number K201467.

Who is the listed applicant for Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B?

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

What is the FDA product code for Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B?

The FDA product code for Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B is DXN.

列明Bioland Technology, 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。

K202739Bioland G-425-2V血糖监测系统，Bioland G-425-2血糖监测系统 K213011红外体温计（型号：E201）K201879数字温度计型号T103，T104 K202934血压计 K201161红外体温计型号E127 K191657Bioland血糖监测系统

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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.

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