MEDI-DX 7000 CPT WITH AMREX ELECTRODES— 510(k) K980866

Substantially Equivalent

Neuro-Diagnostic Assoc.

FDA 510(k) clearance K980866 for MEDI-DX 7000 CPT WITH AMREX ELECTRODES, Substantially Equivalent on 1998-05-20. Applicant: Neuro-Diagnostic Assoc..

Clearance details

Applicant: Neuro-Diagnostic Assoc.
Product code: Code GWF
Advisory panel: Neurology
Date received: 1998-02-19
Decision date: 1998-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Beach, CA, US

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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.