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)

心电图多导联和 IP-SET 总线电缆，单块心电图电缆，SpO2 传感器和 IBP 变送器接口电缆，INTEGRAL PROCESS 总线电缆的心电图导联线，原始总线电缆的心电图导联线

K号: K162768 · 2017-08-16

申请人Integral Process Sas
决定日期2017-08-16
产品代码DSA
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

ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables is the device name listed in this FDA 510(k) record. The listed applicant is Integral Process Sas. It received FDA 510(k) clearance on 2017-08-16 under 510(k) number K162768. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables?

ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables is a medical device that received FDA 510(k) clearance on 2017-08-16. The listed applicant is Integral Process Sas. The 510(k) number is K162768.

When did ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables receive FDA 510(k) clearance?

ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables received FDA 510(k) clearance on 2017-08-16, under 510(k) number K162768.

Who is the listed applicant for ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables?

The FDA 510(k) record lists Integral Process Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables?

The FDA product code for ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables is DSA.

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：DSA）

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。

K254114Baylis 连接器电缆Baylis Medical Technologies, Inc.K252827IBP电缆Becton Dickinson（2606488）；IBP电缆Edwards（2606489）；IBP电缆Abbott, Medex（2606490）；IBP电缆Utah（2606491）；IBP适配器电缆Draeger 7针（2607558）；IBP适配器电缆Draeger 10针（2607559）Drägerwerk AG & Co. KGaAK251669IBP传感器适配器电缆，Argon/BD/Ohmeda，2米；IBP传感器适配器电缆，Draeger 10针，2米；IBP传感器适配器电缆，Draeger 7针，2米；IBP传感器适配器电缆，Abbott/Medex，Smiths/TranStar 2米；IBP传感器适配器电缆，Baxter/Edwards，0.3米；IBP传感器适配器电缆，Baxter/Edwards，2米；IBP传感器适配器电缆，Argon/BD/Ohmeda，0.3米；IBP传感器适配器电缆，Draeger 10针，0.3米；IBP传感器适配器电缆，Draeger 7针，0.3米；IBP传感器适配器Shanghai Draeger Medical Instrument Co., Ltd.K242986SpO2 Extension CableBeijing Rongrui-Century Science & Technology Co., Ltd.K243545Philips可重复使用的ECG导联线和主干电缆：型号编号、型号名称：989803170171，或3导联ECG主干电缆，AAMI/IEC；989803170181，或5导联ECG主干电缆，AAMI/IEC；M1667A，6导联ECG主干，AAMI/IEC 2.7米；M1668A，5导联ECG主干，AAMI/IEC 2.7米；M1669A，3导联ECG主干，AAMI/IEC 2.7米；M1949A，5+5 ECG主干电缆 AAMI，IEC 2.7米；M1663A，10导联ECG主干 AAMI/IEC 2米；M1665A，6+4导联ECG主干 AAMI/IEC 2.7米；M1671A，3导联，抓取器，AAMI，ICU；M1673A，3导联，SnPhilips Medizin Systeme Böblingen GmbHK240087RT Carbon ECG LeadsIvy Biomedical Systems, Inc.

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。

↑