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FDA 510(k)

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005

K-Number: K031260 · 2003-12-19

ApplicantAbbott Diabetes Care, Inc.
Decision Date2003-12-19
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 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 2003-12-19 under 510(k) number K031260. 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 BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005?

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 is a medical device that received FDA 510(k) clearance on 2003-12-19. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K031260.

When did FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 receive FDA 510(k) clearance?

FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 received FDA 510(k) clearance on 2003-12-19, under 510(k) number K031260.

Who is the listed applicant for FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005?

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 BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005?

The FDA product code for FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM, FREESTYLE TRACKER DIABETES MANAGEMENT SYSTEM, MODELS 11001, 16000, AND 16005 is NBW. This falls under the OB/GYN category.

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Other records listing Abbott Diabetes Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemK223435FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemK222447FreeStyle Libre 2 Flash Glucose Monitoring System; Freestyle Libre 3 Continuous Glucose Monitoring SystemK223537FreeStyle Libre 2 System, FreeStyle Libre 3 SystemK213996FreeStyle Libre 3 Continuous Glucose Monitoring SystemK212132FreeStyle Libre 3 Continuous Glucose Monitoring System

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Related Devices (Code: NBW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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