OptiScanner® 5000 Glucose Monitoring System— 510(k) K192785

Name: FDA 510(k) clearance K192785
Creator: U.S. Food and Drug Administration
Published: 2020-02-05

Substantially Equivalent

Optiscan Biomedical Corporation

FDA 510(k) clearance K192785 for OptiScanner® 5000 Glucose Monitoring System, Substantially Equivalent on 2020-02-05. Applicant: Optiscan Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Optiscan Biomedical Corporation
Product code: Code LZF
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2019-09-30
Decision date: 2020-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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K922997 — VIA 1-01 INFUSION PUMP/BLOOD CHEM. SYST. -- MOD.1994-01-11
K920438 — VIA 1-01 INFUSION PUMP BLOOD CHEMISTRY SYSTEM1993-10-22

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