FDA 510(k)

DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080

K-Number: K090628 · 2009-12-04

Decision Date2009-12-04

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 is the device name listed in this FDA 510(k) record. The listed applicant is Bayer Healthcare, LLC. It received FDA 510(k) clearance on 2009-12-04 under 510(k) number K090628. 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 DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080?

DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 is a medical device that received FDA 510(k) clearance on 2009-12-04. The listed applicant is Bayer Healthcare, LLC. The 510(k) number is K090628.

When did DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 receive FDA 510(k) clearance?

DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 received FDA 510(k) clearance on 2009-12-04, under 510(k) number K090628.

Who is the listed applicant for DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080?

The FDA 510(k) record lists Bayer Healthcare, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080?

The FDA product code for DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 is NBW. This falls under the OB/GYN category.

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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.