K232890
- 510(k) number
- K232890
- Device name
- CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
- Applicant
- Integra Lifesciences Production Corporation MA · US
- Product code
- GWM — Device, Monitoring, Intracranial Pressure
- Decision date
- 2024-02-04
- Date received
- 2023-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K232890.pdf
Official FDA record: K232890
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.