K242198
- 510(k) number
- K242198
- Device name
- ICS Dizcovery (1091)
- Applicant
- Natus Medical Denmark Aps DK
- Product code
- GWN — Nystagmograph
- Decision date
- 2025-02-14
- Date received
- 2024-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K242198.pdf
Official FDA record: K242198
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.