ABREU, MODEL 700— 510(k) K100843

Substantially Equivalent

Brain Tunnelgenix Technologies Corp

FDA 510(k) clearance K100843 for ABREU, MODEL 700, Substantially Equivalent on 2010-08-17. Applicant: Brain Tunnelgenix Technologies Corp.

Clearance details

Applicant: Brain Tunnelgenix Technologies Corp
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-03-25
Decision date: 2010-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.