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FDA 510(k)

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System

K-Number: K201037 · 2022-06-16

ApplicantTaidoc Technology Corporation
Decision Date2022-06-16
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is a medical device manufactured by Taidoc Technology Corporation. It received FDA 510(k) clearance on 2022-06-16 under approval number K201037. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is a medical device that received FDA 510(k) clearance on 2022-06-16. It is manufactured by Taidoc Technology Corporation. The 510(k) number is K201037.

When was FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System approved by the FDA?

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System received FDA 510(k) clearance on 2022-06-16, under approval number K201037.

What company makes FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is manufactured by Taidoc Technology Corporation.

What is the FDA product code for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System?

The FDA product code for FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System is NBW. This falls under the OB/GYN category.

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 NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_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)

Other Devices by Taidoc Technology Corporation

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Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

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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