OptiScanner 5000 Glucose Monitoring System

Pump, Infusion, Analytical Sampling

OPTISCAN BIOMEDICAL CORP.

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

Pre-market Notification Details

Device IDK162042
510k NumberK162042
Device Name:OptiScanner 5000 Glucose Monitoring System
ClassificationPump, Infusion, Analytical Sampling
Applicant OPTISCAN BIOMEDICAL CORP. 24590 CLAWITER ROAD Hayward,  CA  94545
ContactDon Webber
CorrespondentDon Webber
OPTISCAN BIOMEDICAL CORP. 24590 CLAWITER ROAD Hayward,  CA  94545
Product CodeLZF  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-25
Decision Date2017-10-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850003892504 K162042 000
00850003892054 K162042 000

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