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FDA 510(k)

BGM009 Plus Blood Glucose Monitoring System

K-Number: K170267 · 2017-03-09

ApplicantApex BioTechnology Corp.
Decision Date2017-03-09
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BGM009 Plus Blood Glucose Monitoring System is a medical device manufactured by Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2017-03-09 under approval number K170267. 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 BGM009 Plus Blood Glucose Monitoring System?

BGM009 Plus Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-03-09. It is manufactured by Apex BioTechnology Corp.. The 510(k) number is K170267.

When was BGM009 Plus Blood Glucose Monitoring System approved by the FDA?

BGM009 Plus Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-03-09, under approval number K170267.

What company makes BGM009 Plus Blood Glucose Monitoring System?

BGM009 Plus Blood Glucose Monitoring System is manufactured by Apex BioTechnology Corp..

What is the FDA product code for BGM009 Plus Blood Glucose Monitoring System?

The FDA product code for BGM009 Plus 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 Apex BioTechnology Corp.

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System K182593KET-1 Blood Ketone Monitoring System K182992BGM014 Blood Glucose Monitoring System K201880MultiSure GK Link Blood Glucose and Ketone Monitoring System K202885GlucoSure HT Plus Blood Glucose Monitoring System K222234GlucoSure ADVANCE Link Blood Glucose Monitoring System

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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