OptiScanner® 5000 Glucose Monitoring System

Pump, Infusion, Analytical Sampling

Optiscan Biomedical Corporation

The following data is part of a premarket notification filed by Optiscan Biomedical Corporation with the FDA for Optiscanner® 5000 Glucose Monitoring System.

Pre-market Notification Details

Device IDK192785
510k NumberK192785
Device Name:OptiScanner® 5000 Glucose Monitoring System
ClassificationPump, Infusion, Analytical Sampling
Applicant Optiscan Biomedical Corporation 24590 Clawiter Road Hayward,  CA  94545
ContactCharles Zimliki
CorrespondentCharles Zimliki
Optiscan Biomedical Corporation 24590 Clawiter Road Hayward,  CA  94545
Product CodeLZF  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelClinical Chemistry
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-30
Decision Date2020-02-05

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.