FDA 510(k)

ReFlow System Mini

K号: K221918 · 2022-09-29

决定日期2022-09-29

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

ReFlow System Mini is the device name listed in this FDA 510(k) record. The listed applicant is Anuncia Medical, Inc.. It received FDA 510(k) clearance on 2022-09-29 under 510(k) number K221918. 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 ReFlow System Mini?

ReFlow System Mini is a medical device that received FDA 510(k) clearance on 2022-09-29. The listed applicant is Anuncia Medical, Inc.. The 510(k) number is K221918.

When did ReFlow System Mini receive FDA 510(k) clearance?

ReFlow System Mini received FDA 510(k) clearance on 2022-09-29, under 510(k) number K221918.

Who is the listed applicant for ReFlow System Mini?

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

What is the FDA product code for ReFlow System Mini?

The FDA product code for ReFlow System Mini is JXG.

列明Anuncia Medical, Inc.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。

K223603Reflow系统迷你和ReFlow迷你冲洗器

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。