FDA 510(k)

FreeStyle Precision Neo Blood Glucose Test Strips

K-Nummer: K171941 · 2017-09-27

Entscheidungsdatum2017-09-27

ProduktcodeNBW

BeratungsausschussCH

EntscheidungSubstantially Equivalent

Produktübersicht

FreeStyle Precision Neo Blood Glucose Test Strips 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 2017-09-27 under 510(k) number K171941. 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.

Häufig gestellte Fragen

What is the FreeStyle Precision Neo Blood Glucose Test Strips?

FreeStyle Precision Neo Blood Glucose Test Strips is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is Abbott Diabetes Care, Inc.. The 510(k) number is K171941.

When did FreeStyle Precision Neo Blood Glucose Test Strips receive FDA 510(k) clearance?

FreeStyle Precision Neo Blood Glucose Test Strips received FDA 510(k) clearance on 2017-09-27, under 510(k) number K171941.

Who is the listed applicant for FreeStyle Precision Neo Blood Glucose Test Strips?

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 Blood Glucose Test Strips?

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

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