K230735
- 510(k) number
- K230735
- Device name
- Ultimate rTMS; Yingchi rTMS
- Applicant
- Brain Ultimate, Inc. GA · US
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2023-09-13
- Date received
- 2023-03-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K230735.pdf
Official FDA record: K230735
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.