FDA 510(k)

GUS610 Blood pressure monitor

K号: K222160 · 2022-11-22

申请人Globalcare Medical Technology Co., Ltd.

决定日期2022-11-22

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

GUS610 Blood pressure monitor is the device name listed in this FDA 510(k) record. The listed applicant is Globalcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-22 under 510(k) number K222160. 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 GUS610 Blood pressure monitor?

GUS610 Blood pressure monitor is a medical device that received FDA 510(k) clearance on 2022-11-22. The listed applicant is Globalcare Medical Technology Co., Ltd.. The 510(k) number is K222160.

When did GUS610 Blood pressure monitor receive FDA 510(k) clearance?

GUS610 Blood pressure monitor received FDA 510(k) clearance on 2022-11-22, under 510(k) number K222160.

Who is the listed applicant for GUS610 Blood pressure monitor?

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

What is the FDA product code for GUS610 Blood pressure monitor?

The FDA product code for GUS610 Blood pressure monitor is DXN.

列明Globalcare Medical 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。

K253896经皮神经电刺激（TENS）/电肌肉刺激器（GUSE01）K250136Globalcare 血压计（GUS610）K192633GUS831 Compressor Nebulizer K192609Globalcare 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.

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