FDA 510(k)

SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System

Número K: K153201 · 2016-06-24

Data da decisão2016-06-24

Código do produtoNBW

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Sd Biosensor. It received FDA 510(k) clearance on 2016-06-24 under 510(k) number K153201. 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 SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System?

SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-06-24. The listed applicant is Sd Biosensor. The 510(k) number is K153201.

When did SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System receive FDA 510(k) clearance?

SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-06-24, under 510(k) number K153201.

Who is the listed applicant for SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System?

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

What is the FDA product code for SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System?

The FDA product code for SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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