GL ULTRASOUND Z/SL 8300— 510(k) K843205

Substantially Equivalent

Gl Ultrasound , Ltd.

FDA 510(k) clearance K843205 for GL ULTRASOUND Z/SL 8300, Substantially Equivalent on 1985-02-25. Applicant: Gl Ultrasound , Ltd..

Clearance details

Applicant: Gl Ultrasound , Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1984-08-14
Decision date: 1985-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Livingston W.Lothian, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.