K243426
- 510(k) number
- K243426
- Device name
- Nurochek-Pro System
- Applicant
- Headsafe Mfg Pty, Ltd. AU
- Product code
- PIW — Brain Injury Adjunctive Interpretive Electroencephal
- Decision date
- 2025-03-27
- Date received
- 2024-11-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K243426.pdf
Official FDA record: K243426
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.