K232991
- 510(k) number
- K232991
- Device name
- BT-1000
- Applicant
- Bistos Co., Ltd. KR
- Product code
- QGL — Transcutaneous Nerve Stimulator For Adhd
- Decision date
- 2024-08-28
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K232991.pdf
Official FDA record: K232991
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.