FDA 510(k)

POGO Automatic Blood Glucose Monitoring System

N.º K: K181316 · 2018-06-14

Fecha de decisión2018-06-14

Código de productoNBW

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

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 2018-06-14 under 510(k) number K181316. 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.

Preguntas frecuentes

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 2018-06-14. The listed applicant is Intuity Medical, Inc.. The 510(k) number is K181316.

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 2018-06-14, under 510(k) number K181316.

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.

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Otros registros que enlistan a Intuity Medical, Inc. como solicitante

K162203POGO Automatic Blood Glucose Monitoring System K152493POGO Automatic Blood Glucose Monitoring System

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Fuente oficial

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