FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

NOVA BIOMEDICAL CORPORATION

The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK131013
510k NumberK131013
Device Name:FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham,  MA  02454
ContactPaul W Macdonald, Phd
CorrespondentPaul W Macdonald, Phd
NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham,  MA  02454
Product CodeNBW  
Subsequent Product CodeJJX
Subsequent Product CodeLFR
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-11
Decision Date2013-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10311917188062 K131013 000
00021292005726 K131013 000
00021292005719 K131013 000
00021292005702 K131013 000

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