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FDA 510(k)

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode

K-Number: K183375 · 2019-02-12

ApplicantHoriba, Ltd.
Decision Date2019-02-12
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is a medical device manufactured by Horiba, Ltd.. It received FDA 510(k) clearance on 2019-02-12 under approval number K183375. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode?

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is a medical device that received FDA 510(k) clearance on 2019-02-12. It is manufactured by Horiba, Ltd.. The 510(k) number is K183375.

When was Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode approved by the FDA?

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode received FDA 510(k) clearance on 2019-02-12, under approval number K183375.

What company makes Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode?

Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is manufactured by Horiba, Ltd..

What is the FDA product code for Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode?

The FDA product code for Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode is JJE.

Related Clinical Trials

NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07556094 Empagliflozin and CPAP in Adults With Heart Failure and Obstructive Sleep Apnea. COMPLETED

Related PubMed Literature

PMID: 41638310 Lower Extremity Complications in Adults With Type 2 Diabetes Treated With Glucagon-Like Peptide-1 Receptor Agonists, Sodium-Glucose Cotransporter 2 Inhibitors, Dipeptidyl Peptidase-4 Inhibitors, and Sulfonylureas: An Emulated Target Trial. Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists (2026) PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 40945659 Comparative Risk of Adverse Pancreatic Events With GLP-1 Receptor Agonists, SGLT2 Inhibitors, DPP4 Inhibitors, and Sulfonylureas Among Adults With Type 2 Diabetes at Moderate Cardiovascular Disease Risk. Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists (2026) PMID: 40673553 Heterogeneity of Cardiovascular Effects of Second-Line Glucose-Lowering Therapies in Adults With Type 2 Diabetes Across the Range of Moderate Baseline Cardiovascular Risk. Journal of the American Heart Association (2025)

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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