FDA 510(k)

GlucoSure ADVANCE Link Blood Glucose Monitoring System

Numéro K : K222234 · 2022-12-21

Date de décision2022-12-21

Code produitNBW

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

GlucoSure ADVANCE Link Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K222234. 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 GlucoSure ADVANCE Link Blood Glucose Monitoring System?

GlucoSure ADVANCE Link Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K222234.

When did GlucoSure ADVANCE Link Blood Glucose Monitoring System receive FDA 510(k) clearance?

GlucoSure ADVANCE Link Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-12-21, under 510(k) number K222234.

Who is the listed applicant for GlucoSure ADVANCE Link Blood Glucose Monitoring System?

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

What is the FDA product code for GlucoSure ADVANCE Link Blood Glucose Monitoring System?

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

Essais cliniques associés

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Source officielle

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