ES-100 POWER SYSTEM, ES-100 SERIES— 510(k) K925360

Substantially Equivalent

Elekta Instruments, Inc.

FDA 510(k) clearance K925360 for ES-100 POWER SYSTEM, ES-100 SERIES, Substantially Equivalent on 1993-09-07. Applicant: Elekta Instruments, Inc..

Clearance details

Applicant: Elekta Instruments, Inc.
Product code: Code GEY
Advisory panel: General, Plastic Surgery
Date received: 1992-10-22
Decision date: 1993-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucker, GA, US

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Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.