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FDA 510(k)

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System

Número K: K160365 · 2016-09-28

RequerenteInfopia Co, Ltd.
Data da decisão2016-09-28
Código do produtoNBW
Comité consultivoCH
DecisãoSubstantially Equivalent

Resumo do dispositivo

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Infopia Co, Ltd.. It received FDA 510(k) clearance on 2016-09-28 under 510(k) number K160365. 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 BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System?

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-09-28. The listed applicant is Infopia Co, Ltd.. The 510(k) number is K160365.

When did BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System receive FDA 510(k) clearance?

BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-09-28, under 510(k) number K160365.

Who is the listed applicant for BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System?

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

What is the FDA product code for BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System?

The FDA product code for BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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