FDA 510(k)

iGlucose Blood Glucose Monitoring System

Numéro K : K161790 · 2017-05-02

Date de décision2017-05-02

Code produitNBW

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

iGlucose Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2017-05-02 under 510(k) number K161790. 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.

Questions fréquentes

What is the iGlucose Blood Glucose Monitoring System?

iGlucose Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-05-02. The listed applicant is Bionime Corporation. The 510(k) number is K161790.

When did iGlucose Blood Glucose Monitoring System receive FDA 510(k) clearance?

iGlucose Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-05-02, under 510(k) number K161790.

Who is the listed applicant for iGlucose Blood Glucose Monitoring System?

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

What is the FDA product code for iGlucose Blood Glucose Monitoring System?

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

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Autres dossiers indiquant Bionime Corporation en tant que demandeur

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Source officielle

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