FDA 510(k)

Système de surveillance de la glycémie en continu Finetest Lite Smart

Numéro K : K201396 · 2020-10-16

Date de décision2020-10-16

Code produitNBW

Comité consultatifCH

DécisionSubstantially Equivalent

Résumé du dispositif

Finetest Lite Smart Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Osang Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K201396. 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 Finetest Lite Smart Blood Glucose Monitoring System?

Finetest Lite Smart Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Osang Healthcare Co. , Ltd.. The 510(k) number is K201396.

When did Finetest Lite Smart Blood Glucose Monitoring System receive FDA 510(k) clearance?

Finetest Lite Smart Blood Glucose Monitoring System received FDA 510(k) clearance on 2020-10-16, under 510(k) number K201396.

Who is the listed applicant for Finetest Lite Smart Blood Glucose Monitoring System?

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

What is the FDA product code for Finetest Lite Smart Blood Glucose Monitoring System?

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

Essais cliniques associés

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Autres dossiers indiquant Osang Healthcare Co. , Ltd. en tant que demandeur

K203562Finetest Lite Blood Glucose Monitoring System K182286Oh'Care Lite Smart Blood Glucose Monitoring System

Dispositifs connexes (Code : NBW)

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Source officielle

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