K242306
- 510(k) number
- K242306
- Device name
- SignalNED System (Model RE)
- Applicant
- Forest Devices, Inc. PA · US
- Product code
- OMC — Reduced- Montage Standard Electroencephalograph
- Decision date
- 2024-09-04
- Date received
- 2024-08-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K242306.pdf
Official FDA record: K242306
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.