OptiScanner 5000 Glucose Monitoring System— 510(k) K162042

Name: FDA 510(k) clearance K162042
Creator: U.S. Food and Drug Administration
Published: 2017-10-16

Substantially Equivalent

Optiscan Biomedical Corp.

FDA 510(k) clearance K162042 for OptiScanner 5000 Glucose Monitoring System, Substantially Equivalent on 2017-10-16. Applicant: Optiscan Biomedical Corp.. Device class: 2.

Clearance details

Applicant: Optiscan Biomedical Corp.
Product code: Code LZF
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2016-07-25
Decision date: 2017-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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