DAUM-LECTRIC MRI DRILLING MACHINE— 510(k) K021098

Substantially Equivalent

Mri Devices Daum GmbH

FDA 510(k) clearance K021098 for DAUM-LECTRIC MRI DRILLING MACHINE, Substantially Equivalent on 2002-12-03. Applicant: Mri Devices Daum GmbH.

Clearance details

Applicant: Mri Devices Daum GmbH
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2002-04-04
Decision date: 2002-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton,, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.