FDA 510(k)

带听诊器的血压计，水银血压计

K号: K192500 · 2020-04-06

决定日期2020-04-06

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

Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer is the device name listed in this FDA 510(k) record. The listed applicant is Honsun (Nantong) Co., Ltd.. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K192500. 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 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer?

Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Honsun (Nantong) Co., Ltd.. The 510(k) number is K192500.

When did Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer receive FDA 510(k) clearance?

Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer received FDA 510(k) clearance on 2020-04-06, under 510(k) number K192500.

Who is the listed applicant for Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer?

FDA 510(k)记录将江苏恒生医疗器械有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer?

The FDA product code for Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer is DXQ.

列明Honsun (Nantong) 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。

K262658自动数字血压计（LD-526）K252399便携式制氧机 K260260自动数字血压计（LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569）K251795手腕式自动血压计（LD-735，LD-752，LD-753）K211629红外额温计 LD-FT-100B K170866Scian自动数字血压计，型号：LD-576，LD-575 & LD-579

查看所有 9 个设备 →

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。