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FDA 510(k)

Signos Glucose Monitoring System

K-Number: K250106 · 2025-03-21

ApplicantSignos, Inc.
Decision Date2025-03-21
Product CodeSAF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Signos Glucose Monitoring System is a medical device manufactured by Signos, Inc.. It received FDA 510(k) clearance on 2025-03-21 under approval number K250106. 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 Signos Glucose Monitoring System?

Signos Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Signos, Inc.. The 510(k) number is K250106.

When was Signos Glucose Monitoring System approved by the FDA?

Signos Glucose Monitoring System received FDA 510(k) clearance on 2025-03-21, under approval number K250106.

What company makes Signos Glucose Monitoring System?

Signos Glucose Monitoring System is manufactured by Signos, Inc..

What is the FDA product code for Signos Glucose Monitoring System?

The FDA product code for Signos Glucose Monitoring System is SAF.

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: SAF)

K233655Lingo Glucose SystemAbbott K234070Stelo Glucose Biosensor SystemDexcom, Inc.

Official Source

View on FDA Database →

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