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FDA 510(k)

OptiScanner® 5000 Glucose Monitoring System

K-Number: K192785 · 2020-02-05

ApplicantOptiscan Biomedical Corporation
Decision Date2020-02-05
Product CodeLZF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OptiScanner® 5000 Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Optiscan Biomedical Corporation. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K192785. 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 2020-02-05. The listed applicant is Optiscan Biomedical Corporation. The 510(k) number is K192785.

When did OptiScanner® 5000 Glucose Monitoring System receive FDA 510(k) clearance?

OptiScanner® 5000 Glucose Monitoring System received FDA 510(k) clearance on 2020-02-05, under 510(k) number K192785.

Who is the listed applicant for OptiScanner® 5000 Glucose Monitoring System?

The FDA 510(k) record lists Optiscan Biomedical Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Optiscan Biomedical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162042OptiScanner 5000 Glucose Monitoring System

Related Devices (Code: LZF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162042OptiScanner 5000 Glucose Monitoring SystemOptiscan Biomedical Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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