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FDA 510(k)

Meridian M110胎儿监护系统

K号: K161902 · 2017-01-12

决定日期2017-01-12
产品代码HGM
咨询委员会OB 请注意,由于您没有提供具体的医疗设备监管文本,我无法进行翻译。请提供具体的文本内容,以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Meridian M110 Fetal Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Mindchild Medical. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K161902. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Meridian M110 Fetal Monitoring System?

Meridian M110 Fetal Monitoring System is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Mindchild Medical. The 510(k) number is K161902.

When did Meridian M110 Fetal Monitoring System receive FDA 510(k) clearance?

Meridian M110 Fetal Monitoring System received FDA 510(k) clearance on 2017-01-12, under 510(k) number K161902.

Who is the listed applicant for Meridian M110 Fetal Monitoring System?

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

What is the FDA product code for Meridian M110 Fetal Monitoring System?

The FDA product code for Meridian M110 Fetal Monitoring System is HGM.

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。

相关器械(代码:HGM)

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。

官方来源

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