510(k) K183406 ยท GWM Device, Monitoring, Intracranial Pressure
CereLink ICP Monitor, CereLink ICP Extension Cable
| Applicant | Integra Lifesciences Corp., Mansfield MA, US |
| Decision | Substantially Equivalent, Jan 11, 2019 |
| Received | Dec 10, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183406
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 12, 2019 | Integra LifeSciences Corp. Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. Open, Classified |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.