IONOMETER EF AND ACCESSORIES— 510(k) K870183

Name: FDA 510(k) clearance K870183
Creator: U.S. Food and Drug Administration
Published: 1987-05-12

Substantially Equivalent

Smash Ent., Inc.

FDA 510(k) clearance K870183 for IONOMETER EF AND ACCESSORIES, Substantially Equivalent on 1987-05-12. Applicant: Smash Ent., Inc.. Device class: 2.

Clearance details

Applicant: Smash Ent., Inc.
Product code: Code JGS
Device class: Class 2
Regulation: 21 CFR 862.1665
Advisory panel: Clinical Chemistry
Date received: 1987-01-16
Decision date: 1987-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shoreview, MN, 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.