FDA 510(k)手臂式全自动数字血压计（DBP-6286B, DBP-6186）
K号: K250548 · 2025-06-26
决定日期2025-06-26
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 Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) is the device name listed in this FDA 510(k) record. The listed applicant is Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2025-06-26 under 510(k) number K250548. 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 Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)?
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) is a medical device that received FDA 510(k) clearance on 2025-06-26. The listed applicant is Joytech Healthcare Co. , Ltd.. The 510(k) number is K250548.
When did Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) receive FDA 510(k) clearance?
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) received FDA 510(k) clearance on 2025-06-26, under 510(k) number K250548.
Who is the listed applicant for Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)?
FDA 510(k)记录将Joytech Healthcare Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)?
The FDA product code for Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) is DXN.
相关临床试验
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。
列明Joytech Healthcare 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。
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）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）K252501手臂式全自动数字血压计（DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L）K252685手臂式全自动数字血压计（DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P）K243468压缩机雾化器（NB-1100）；压缩机雾化器（NB-1101）；压缩机雾化器（NB-1102）；压缩机雾化器（NB-1103）K241431手臂式全自动数字血压计（DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193） 查看所有 24 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.