K233631
- 510(k) number
- K233631
- Device name
- ZapStim Controller Application (Z1023)
- Applicant
- Revital Lab, Inc. NV · US
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2024-02-09
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233631.pdf
Official FDA record: K233631
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.