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FDA 510(k)

Lingo Glucose System

K-Number: K233655 · 2024-05-29

ApplicantAbbott
Decision Date2024-05-29
Product CodeSAF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Lingo Glucose System is a medical device manufactured by Abbott. It received FDA 510(k) clearance on 2024-05-29 under approval number K233655. The device is classified under product code SAF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lingo Glucose System?

Lingo Glucose System is a medical device that received FDA 510(k) clearance on 2024-05-29. It is manufactured by Abbott. The 510(k) number is K233655.

When was Lingo Glucose System approved by the FDA?

Lingo Glucose System received FDA 510(k) clearance on 2024-05-29, under approval number K233655.

What company makes Lingo Glucose System?

Lingo Glucose System is manufactured by Abbott.

What is the FDA product code for Lingo Glucose System?

The FDA product code for Lingo Glucose System is SAF.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 37272495 An Empirical Review of Key Glucose Monitoring Devices: Product Iterations and Patent Protection. Journal of diabetes science and technology (2025)

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Related Devices (Code: SAF)

K234070Stelo Glucose Biosensor SystemDexcom, Inc. K250106Signos Glucose Monitoring SystemSignos, Inc.

Official Source

View on FDA Database →

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

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