FDA 510(k)

FreeStyle Precision Neo H Blood Glucose Monitoring System

K-Number: K153330 · 2016-02-19

Decision Date2016-02-19

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

FreeStyle Precision Neo H Blood Glucose Monitoring 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 2016-02-19 under 510(k) number K153330. 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 Precision Neo H Blood Glucose Monitoring System?

FreeStyle Precision Neo H Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-02-19. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K153330.

When did FreeStyle Precision Neo H Blood Glucose Monitoring System receive FDA 510(k) clearance?

FreeStyle Precision Neo H Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-02-19, under 510(k) number K153330.

Who is the listed applicant for FreeStyle Precision Neo H Blood Glucose Monitoring 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 Precision Neo H Blood Glucose Monitoring System?

The FDA product code for FreeStyle Precision Neo H Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Other records listing Abbott Diabetes Care, Inc. as applicant

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Related Devices (Code: NBW)

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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.