SAPPHIRE PREMIERE— 510(k) K923303

Substantially Equivalent

Medelec , Ltd.

FDA 510(k) clearance K923303 for SAPPHIRE PREMIERE, Substantially Equivalent on 1992-11-24. Applicant: Medelec , Ltd..

Clearance details

Applicant: Medelec , Ltd.
Product code: Code GWF
Advisory panel: Neurology
Date received: 1992-07-06
Decision date: 1992-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Surrey, England Gu22 9ju, GB

Download summary PDF View on FDA.gov ↗

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.