K242930
- 510(k) number
- K242930
- Device name
- Natus BrainWatch System
- Applicant
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) CA
- Product code
- OMC — Reduced- Montage Standard Electroencephalograph
- Decision date
- 2024-11-19
- Date received
- 2024-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K242930.pdf
Official FDA record: K242930
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.