MODIFIED SODIUM ELECTRODE— 510(k) K863907

Name: FDA 510(k) clearance K863907
Creator: U.S. Food and Drug Administration
Published: 1986-12-10

Substantially Equivalent

Ionetics, Inc.

FDA 510(k) clearance K863907 for MODIFIED SODIUM ELECTRODE, Substantially Equivalent on 1986-12-10. Applicant: Ionetics, Inc.. Device class: 2.

Clearance details

Applicant: Ionetics, Inc.
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 1986-10-07
Decision date: 1986-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.