FDA 510(k)

Nova Max 尿酸监控系统

K号: K160990 · 2017-04-11

决定日期2017-04-11

产品代码PTC

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。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

Nova Max Uric Acid Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corporation. It received FDA 510(k) clearance on 2017-04-11 under 510(k) number K160990. The device is classified under product code PTC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nova Max Uric Acid Monitoring System?

Nova Max Uric Acid Monitoring System is a medical device that received FDA 510(k) clearance on 2017-04-11. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K160990.

When did Nova Max Uric Acid Monitoring System receive FDA 510(k) clearance?

Nova Max Uric Acid Monitoring System received FDA 510(k) clearance on 2017-04-11, under 510(k) number K160990.

Who is the listed applicant for Nova Max Uric Acid Monitoring System?

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

What is the FDA product code for Nova Max Uric Acid Monitoring System?

The FDA product code for Nova Max Uric Acid Monitoring System is PTC.

列明Nova Biomedical Corporation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。

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官方来源

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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。