FDA 510(k)

XPER技术 PREMIUM Pro 血糖监测系统

K号: K221349 · 2024-11-19

决定日期2024-11-19

产品代码PZI

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

XPER Technology PREMIUM Pro Blood Glucose 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 2024-11-19 under 510(k) number K221349. The device is classified under product code PZI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XPER Technology PREMIUM Pro Blood Glucose Monitoring System?

XPER Technology PREMIUM Pro Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2024-11-19. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K221349.

When did XPER Technology PREMIUM Pro Blood Glucose Monitoring System receive FDA 510(k) clearance?

XPER Technology PREMIUM Pro Blood Glucose Monitoring System received FDA 510(k) clearance on 2024-11-19, under 510(k) number K221349.

Who is the listed applicant for XPER Technology PREMIUM Pro Blood Glucose 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 XPER Technology PREMIUM Pro Blood Glucose Monitoring System?

The FDA product code for XPER Technology PREMIUM Pro Blood Glucose Monitoring System is PZI.

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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