Ampa One System (AMPA-001)— 510(k) K251210
Substantially EquivalentNeuromodulatory Devices & Applications
FDA 510(k) clearance K251210 for Ampa One System (AMPA-001), Substantially Equivalent on 2025-06-27. Applicant: Neuromodulatory Devices & Applications.
Clearance details
- Applicant
- Neuromodulatory Devices & Applications
- Product code
- Code OBP
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Adverse events under product code OBP
product code OBP- Injury
- 270
- Total
- 270
Source: openFDA MAUDE database, through . 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.