FDA 510(k)

可重复使用血压袖带

K号: K171889 · 2017-12-19

申请人Suzhou Minhua Medical Apparatus Supplies Co., Ltd.

决定日期2017-12-19

产品代码DXQ

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

Reusable Blood Pressure Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. It received FDA 510(k) clearance on 2017-12-19 under 510(k) number K171889. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reusable Blood Pressure Cuff?

Reusable Blood Pressure Cuff is a medical device that received FDA 510(k) clearance on 2017-12-19. The listed applicant is Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. The 510(k) number is K171889.

When did Reusable Blood Pressure Cuff receive FDA 510(k) clearance?

Reusable Blood Pressure Cuff received FDA 510(k) clearance on 2017-12-19, under 510(k) number K171889.

Who is the listed applicant for Reusable Blood Pressure Cuff?

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

What is the FDA product code for Reusable Blood Pressure Cuff?

The FDA product code for Reusable Blood Pressure Cuff is DXQ.

列明Suzhou Minhua Medical Apparatus Supplies 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。

K241096维纳斯608深静脉血栓（DVT）预防系统 K233276可重复使用血压袖带 K180389维纳斯508深静脉血栓（DVT）预防系统

相关器械（代码：DXQ）

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。

K254287Medline 可重复使用血压袖带Medline Industries, LP K260747YP-710T系列血压计袖带；YP-840T系列一次性袖带Nihon Kohden Corporation K253089NIBP袖带（BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722）Shenzhen Best Electronics Co., Ltd.K253964一次性新生儿NIBP袖带（U1681S-C51N）Unimed Medical Supplies, Inc.K251745韦尔奇·艾略恩FlexiPort血压袖带（FlexiPort血压袖带）Baxter Healthcare Corporation K250765AViTA 臂式血压计袖带Avita Corporation

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。