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FDA 510(k)

Wireless Smart Gluco-Monitoring System

Número K: K153278 · 2016-08-19

RequerenteAndon Health Co, Ltd.
Data da decisão2016-08-19
Código do produtoNBW
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

Wireless Smart Gluco-Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K153278. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wireless Smart Gluco-Monitoring System?

Wireless Smart Gluco-Monitoring System is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Andon Health Co, Ltd.. The 510(k) number is K153278.

When did Wireless Smart Gluco-Monitoring System receive FDA 510(k) clearance?

Wireless Smart Gluco-Monitoring System received FDA 510(k) clearance on 2016-08-19, under 510(k) number K153278.

Who is the listed applicant for Wireless Smart Gluco-Monitoring System?

The FDA 510(k) record lists Andon Health Co, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless Smart Gluco-Monitoring System?

The FDA product code for Wireless Smart Gluco-Monitoring System is NBW. This falls under the OB/GYN category.

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Fonte oficial

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