JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381

System, Test, Blood Glucose, Over The Counter

AGAMATRIX INC

The following data is part of a premarket notification filed by Agamatrix Inc with the FDA for Jazz Wireless Blood Glucose Monitoring System, Model 8000-03381.

Pre-market Notification Details

Device IDK083265
510k NumberK083265
Device Name:JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant AGAMATRIX INC 10 MANOR PARKWAY Salem,  NH  03079
ContactConnie Hertel
CorrespondentConnie Hertel
AGAMATRIX INC 10 MANOR PARKWAY Salem,  NH  03079
Product CodeNBW  
Subsequent Product CodeCGA
Subsequent Product CodeJJX
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-05
Decision Date2009-02-03
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.