FDA 510(k)

POGO Automatic Blood Glucose Monitoring System

K-Number: K181316 · 2018-06-14

Decision Date2018-06-14

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

POGO Automatic Blood Glucose Monitoring System is a medical device manufactured by Intuity Medical, Inc.. It received FDA 510(k) clearance on 2018-06-14 under approval 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.

Frequently Asked Questions

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. It is manufactured by Intuity Medical, Inc.. The 510(k) number is K181316.

When was POGO Automatic Blood Glucose Monitoring System approved by the FDA?

POGO Automatic Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-06-14, under approval number K181316.

What company makes POGO Automatic Blood Glucose Monitoring System?

POGO Automatic Blood Glucose Monitoring System is manufactured by Intuity Medical, Inc..

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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Related PubMed Literature

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Other Devices by Intuity Medical, Inc.

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

Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

Official Source

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