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FDA 510(k)

OptiScanner 5000 Glucose Monitoring System

K-Number: K162042 · 2017-10-16

ApplicantOptiscan Biomedical Corp.
Decision Date2017-10-16
Product CodeLZF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OptiScanner 5000 Glucose Monitoring System is a medical device manufactured by Optiscan Biomedical Corp.. It received FDA 510(k) clearance on 2017-10-16 under approval number K162042. The device is classified under product code LZF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiScanner 5000 Glucose Monitoring System?

OptiScanner 5000 Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-10-16. It is manufactured by Optiscan Biomedical Corp.. The 510(k) number is K162042.

When was OptiScanner 5000 Glucose Monitoring System approved by the FDA?

OptiScanner 5000 Glucose Monitoring System received FDA 510(k) clearance on 2017-10-16, under approval number K162042.

What company makes OptiScanner 5000 Glucose Monitoring System?

OptiScanner 5000 Glucose Monitoring System is manufactured by Optiscan Biomedical Corp..

What is the FDA product code for OptiScanner 5000 Glucose Monitoring System?

The FDA product code for OptiScanner 5000 Glucose Monitoring System is LZF.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07599982 Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes RECRUITING NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026) PMID: 41964171 Journal of diabetes science and technology (2026) PMID: 41760572 Trends in use of continuous glucose monitors among individuals with type 2 diabetes enrolled in Medicare Advantage (2021-2023). Journal of managed care & specialty pharmacy (2026)

Related Devices (Code: LZF)

K192785OptiScanner® 5000 Glucose Monitoring SystemOptiscan Biomedical Corporation

Official Source

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