FDA 510(k)

Polaris 阀电子读数仪

K号: K222422 · 2023-02-02

决定日期2023-02-02

产品代码JXG

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Polaris Valve Electronic Reading Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K222422. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Polaris Valve Electronic Reading Instrument?

Polaris Valve Electronic Reading Instrument is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Sophysa. The 510(k) number is K222422.

When did Polaris Valve Electronic Reading Instrument receive FDA 510(k) clearance?

Polaris Valve Electronic Reading Instrument received FDA 510(k) clearance on 2023-02-02, under 510(k) number K222422.

Who is the listed applicant for Polaris Valve Electronic Reading Instrument?

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

What is the FDA product code for Polaris Valve Electronic Reading Instrument?

The FDA product code for Polaris Valve Electronic Reading Instrument is JXG.

列明Sophysa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。

K252241Pressio 3多参数神经监测系统 K250636Sophy Mini 单压力阀 (SM1)K242974外部脑脊液引流室导管，外部脑脊液引流腰椎导管

相关器械（代码：JXG）

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。

K261004Codman®远端腹膜导管，钡开放端（82-1682）；Codman®HOLTER®腹膜导管（SALMON设计）（82-1684）Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini 单压力阀 (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531Codman Libertís分流导管，带Bactiseal和Endexo技术Integra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821761）；Codman Libertís™ 1.9 mm EVD导管，带Bactiseal®和Endexo®技术，带Luer连接（821762）Integra Lifesciences Production 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。