FDA 510(k)

FORA MD6 尿酸监测系统，FORA MD6 Pro 尿酸监测系统

K号: K181675 · 2018-12-10

决定日期2018-12-10

产品代码PTC

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决定实质等同

器械摘要

FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K181675. 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 FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System?

FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K181675.

When did FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System receive FDA 510(k) clearance?

FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System received FDA 510(k) clearance on 2018-12-10, under 510(k) number K181675.

Who is the listed applicant for FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System?

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

What is the FDA product code for FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System?

The FDA product code for FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System is PTC.

列明Taidoc Technology 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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