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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Analytical Sampling
510(k) Number K192785
Device Name OptiScanner® 5000 Glucose Monitoring System
Applicant
Optiscan Biomedical Corporation
24590 Clawiter Rd.
Hayward,  CA  94545
Applicant Contact Charles Zimliki
Correspondent
Optiscan Biomedical Corporation
24590 Clawiter Rd.
Hayward,  CA  94545
Correspondent Contact Charles Zimliki
Regulation Number880.5725
Classification Product Code
LZF  
Subsequent Product Code
PYV  
Date Received09/30/2019
Decision Date 02/05/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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