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510(k) K192785

Device
OptiScanner® 5000 Glucose Monitoring System
Applicant
Optiscan Biomedical Corporation
510(k) number
K192785
Product code
LZF  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-05
Date received
2019-09-30
Regulation
880.5725
Classification name
Pump, Infusion, Analytical Sampling
Medical specialty
General Hospital
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Charles Zimliki
Address
24590 Clawiter Rd. Hayward CA US 94545 94545

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.2017-10-16
K011238RODA (REAL TIME OXYGEN DYNAMICS ANALYSIS) MONITORING SYSTEMMetracor Technologies, Inc.2002-01-08
K951739PUMP/BLOOD CHEMISTRY MONITORVia Medical Corp.1996-02-28
K922997VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.Via Medical Corp.1994-01-11
K920438VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEMVia Medical Corp.1993-10-22
K882830INFUSION PUMPPemlab Corp.1988-12-30

Legacy Summary#

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FDA Review#

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