FDA 510(k)

FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM

K-Number: K020866 · 2002-06-11

Decision Date2002-06-11

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Diabetes Care, Inc.. It received FDA 510(k) clearance on 2002-06-11 under 510(k) number K020866. 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 FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM?

FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-11. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K020866.

When did FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM receive FDA 510(k) clearance?

FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM received FDA 510(k) clearance on 2002-06-11, under 510(k) number K020866.

Who is the listed applicant for FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM?

The FDA 510(k) record lists Abbott Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM?

The FDA product code for FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM is NBW. This falls under the OB/GYN category.

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Other records listing Abbott Diabetes Care, Inc. as applicant

K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System K223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System K222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring System K223537FreeStyle Libre 2 System, FreeStyle Libre 3 System K213996FreeStyle Libre 3 Continuous Glucose Monitoring System K212132FreeStyle Libre 3 Continuous Glucose Monitoring System

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Official Source

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