T65 (9016E061-)— 510(k) K252032

Substantially Equivalent

Tonica Elektronik A/S

FDA 510(k) clearance K252032 for T65 (9016E061-), Substantially Equivalent on 2025-07-30. Applicant: Tonica Elektronik A/S.

Clearance details

Applicant: Tonica Elektronik A/S
Product code: Code OBP
Advisory panel: Neurology
Date received: 2025-06-30
Decision date: 2025-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Farum, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

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.