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FDA 510(k)

FORA GTel Blood Glucose Monitoring System

K-Number: K173505 · 2018-08-09

ApplicantForacare, Inc.
Decision Date2018-08-09
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FORA GTel Blood Glucose Monitoring System is a medical device manufactured by Foracare, Inc.. It received FDA 510(k) clearance on 2018-08-09 under approval number K173505. 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 FORA GTel Blood Glucose Monitoring System?

FORA GTel Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Foracare, Inc.. The 510(k) number is K173505.

When was FORA GTel Blood Glucose Monitoring System approved by the FDA?

FORA GTel Blood Glucose Monitoring System received FDA 510(k) clearance on 2018-08-09, under approval number K173505.

What company makes FORA GTel Blood Glucose Monitoring System?

FORA GTel Blood Glucose Monitoring System is manufactured by Foracare, Inc..

What is the FDA product code for FORA GTel Blood Glucose Monitoring System?

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

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Related PubMed Literature

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Related Devices (Code: NBW)

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Official Source

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