FDA 510(k)

POGO Automatic Blood Glucose Monitoring System

Numéro K : K152493 · 2016-04-25

Date de décision2016-04-25

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

POGO Automatic Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Intuity Medical, Inc.. It received FDA 510(k) clearance on 2016-04-25 under 510(k) number K152493. 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 POGO Automatic Blood Glucose Monitoring System?

POGO Automatic Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-04-25. The listed applicant is Intuity Medical, Inc.. The 510(k) number is K152493.

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

POGO Automatic Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-04-25, under 510(k) number K152493.

Who is the listed applicant for POGO Automatic Blood Glucose Monitoring System?

The FDA 510(k) record lists Intuity Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Essais cliniques associés

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Autres dossiers indiquant Intuity Medical, Inc. en tant que demandeur

K181316POGO Automatic Blood Glucose Monitoring System K162203POGO Automatic Blood Glucose Monitoring System

Dispositifs connexes (Code : NBW)

K260545Système de surveillance de la glycémie CONTOUR® PLUS BLUE; Système de surveillance de la glycémie CONTOUR® NEXT GEN; Système de surveillance de la glycémie CONTOUR® NEXT ONEAscensia Diabetes Care K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc.K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring SystemACON Laboratories, Inc.K243060TeleRPM Gen2 Blood Glucose Monitoring SystemGuangdong Transtek Medical Electronics Co., Ltd.K240637RIGHTEST Blood Glucose Monitoring System Max TelBionime Corporation K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd.

Source officielle

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