510(k) K912775— SAPPHIRE 4ME EMG/EP SYSTEM

Substantially Equivalent

Medelec Intl. Corp.

Clearance details

Applicant: Medelec Intl. Corp.
Product code: Code GWF
Advisory panel: Neurology
Date received: 1991-06-24
Decision date: 1991-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: England, GB

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.