CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER

Glucose Dehydrogenase, Glucose

BAYER HEALTHCARE

The following data is part of a premarket notification filed by Bayer Healthcare with the FDA for Contour Next Link Wireless Blood Glucose Meter.

Pre-market Notification Details

Device IDK110894
510k NumberK110894
Device Name:CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
ClassificationGlucose Dehydrogenase, Glucose
Applicant BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka,  IN  46544
ContactRoger Sonnenburg
CorrespondentRoger Sonnenburg
BAYER HEALTHCARE 430 SOUTH BEIGER STREET Mishawaka,  IN  46544
Product CodeLFR  
Subsequent Product CodeJJX
Subsequent Product CodeNBW
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-03-30
Decision Date2012-03-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40301939632019 K110894 000
40301939624014 K110894 000
40301936203014 K110894 000
40301936201010 K110894 000

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