患者监护电缆
K号: K203635 · 2021-02-05
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申请人Jkh USA, LLC
决定日期2021-02-05
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：
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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
Patient Monitoring Cables is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K203635. 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 Patient Monitoring Cables?
Patient Monitoring Cables is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Jkh USA, LLC. The 510(k) number is K203635.
When did Patient Monitoring Cables receive FDA 510(k) clearance?
Patient Monitoring Cables received FDA 510(k) clearance on 2021-02-05, under 510(k) number K203635.
Who is the listed applicant for Patient Monitoring Cables?
The FDA 510(k) record lists Jkh USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Patient Monitoring Cables?
The FDA product code for Patient Monitoring 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。
列明Jkh USA, LLC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。
K203636PlusCare 温度探头，皮肤类型：PT2252-AS，PTHP-AS，PTMQ-AS，PTSW-AS，PTSM-15AS，PTSL-AS，PTMR-AS；直肠类型：PT2252-AG，PTHP-AG，PTMQ-AG，PTSW-AG，PTSM-15AG，PTSL-AG，PTMR-AGK203652血压计，U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, 血压计，U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, 血压计，U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, 血压计，U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, 血压计，U1770S, U1790s, U1710D, U1720D, U1730D, U1740DK202851Spo2传感器K201645按摩压缩靴K201470一次性医用口罩K182671Medi-Direct TENS 笔
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。
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