免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

Tenso TS-101S和TS-101D一次性血压袖带

K号: K153251 · 2016-04-14

申请人Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.
决定日期2016-04-14
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

Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2016-04-14 under 510(k) number K153251. 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 Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff?

Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff is a medical device that received FDA 510(k) clearance on 2016-04-14. The listed applicant is Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd.. The 510(k) number is K153251.

When did Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff receive FDA 510(k) clearance?

Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff received FDA 510(k) clearance on 2016-04-14, under 510(k) number K153251.

Who is the listed applicant for Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff?

The FDA 510(k) record lists Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff?

The FDA product code for Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff is DXQ.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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, LPK260747YP-710T系列血压计袖带；YP-840T系列一次性袖带Nihon Kohden CorporationK253089NIBP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 CorporationK250765AViTA 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。

↑