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

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.

Clearance details

Applicant
Optiscan Biomedical Corporation
Product code
Code LZF
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Hayward, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.