K241160
- 510(k) number
- K241160
- Device name
- CAIs Sensor (CAIs-001)
- Applicant
- Brainu Co., Ltd. KR
- Product code
- GXY — Electrode, Cutaneous
- Decision date
- 2024-12-13
- Date received
- 2024-04-26
- 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: K241160.pdf
Official FDA record: K241160
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.