510(k) K243319— Ampa One System (AMPA-001)

Substantially Equivalent

Neuromodulatory Devices & Applications

Clearance details

Applicant: Neuromodulatory Devices & Applications
Product code: Code OBP
Advisory panel: Neurology
Date received: 2024-10-23
Decision date: 2025-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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.