FDA 510(k)

Dario LC Blood Glucose Monitoring System

Numéro K : K172723 · 2018-03-23

Date de décision2018-03-23

Code produitNBW

Comité consultatifCH Politique : medical-regulatory-v1 Description du texte réglementaire pour dispositif médical : CH Politique : medical-regulatory-v1 Description du texte réglementaire pour dispositif médical : [Original text in English follows, as the translation was not provided in the prompt.]

DécisionSubstantially Equivalent

Résumé du dispositif

Dario LC Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Labstyle Innovation, Ltd.. It received FDA 510(k) clearance on 2018-03-23 under 510(k) number K172723. 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 Dario LC Blood Glucose Monitoring System?

Dario LC Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-03-23. The listed applicant is Labstyle Innovation, Ltd.. The 510(k) number is K172723.

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

Dario LC Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-03-23, under 510(k) number K172723.

Who is the listed applicant for Dario LC Blood Glucose Monitoring System?

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

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

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

Essais cliniques associés

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Dispositifs connexes (Code : NBW)

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Source officielle

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