Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode— 510(k) K183375

Substantially Equivalent

Horiba, Ltd.

FDA 510(k) clearance K183375 for Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode, Substantially Equivalent on 2019-02-12. Applicant: Horiba, Ltd..

Clearance details

Applicant: Horiba, Ltd.
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 2018-12-06
Decision date: 2019-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kyoto, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.