K243319
- 510(k) number
- K243319
- Device name
- Ampa One System (AMPA-001)
- Applicant
- Neuromodulatory Devices & Applications CA · US
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2025-02-13
- Date received
- 2024-10-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243319.pdf
Official FDA record: K243319
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.