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FDA 510(k)

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System

K-Number: K153561 · 2017-02-16

ApplicantAndon Health Co, Ltd.
Decision Date2017-02-16
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System is a medical device manufactured by Andon Health Co, Ltd.. It received FDA 510(k) clearance on 2017-02-16 under approval number K153561. 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 AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System?

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-02-16. It is manufactured by Andon Health Co, Ltd.. The 510(k) number is K153561.

When was AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System approved by the FDA?

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-02-16, under approval number K153561.

What company makes AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System?

AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System is manufactured by Andon Health Co, Ltd..

What is the FDA product code for AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System?

The FDA product code for AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Other Devices by Andon Health Co, Ltd.

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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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