FDA 510(k)

MyGlucoHealth Wireless System

Número K: K143169 · 2016-01-08

Data da decisão2016-01-08

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

MyGlucoHealth Wireless System is the device name listed in this FDA 510(k) record. The listed applicant is Entra Health Systems. It received FDA 510(k) clearance on 2016-01-08 under 510(k) number K143169. 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 MyGlucoHealth Wireless System?

MyGlucoHealth Wireless System is a medical device that received FDA 510(k) clearance on 2016-01-08. The listed applicant is Entra Health Systems. The 510(k) number is K143169.

When did MyGlucoHealth Wireless System receive FDA 510(k) clearance?

MyGlucoHealth Wireless System received FDA 510(k) clearance on 2016-01-08, under 510(k) number K143169.

Who is the listed applicant for MyGlucoHealth Wireless System?

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

What is the FDA product code for MyGlucoHealth Wireless System?

The FDA product code for MyGlucoHealth Wireless System is NBW. This falls under the OB/GYN category.

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