K233001
- 510(k) number
- K233001
- Device name
- Bioscope Neuromonitor Device
- Applicant
- Biosys Biyomedikal Muhendislik San. VE Tic. A.S. TR
- Product code
- ETN — Stimulator, Nerve
- Decision date
- 2024-12-13
- Date received
- 2023-09-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K233001.pdf
Official FDA record: K233001
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.