K243520
- 510(k) number
- K243520
- Device name
- Bullsai Confirm
- Applicant
- Turing Medical Technologies, Inc. MO · US
- Product code
- QQC — Brain Stimulation Programming Planning Software.
- Decision date
- 2025-03-28
- Date received
- 2024-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243520.pdf
Official FDA record: K243520
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.