510(k) K822864 ยท GWM Device, Monitoring, Intracranial Pressure
INTRACRANIAL PRESSURE MONITORING DEVICE
| Applicant | Medex, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Nov 16, 1982 |
| Received | Sep 27, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822864
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2006 | Medex Inc MX6160R1, Custom CIPER (Comprehensive Intracranial Presssure Evaluation and Relief) System. The product is packaged in a tyvek pouch and is sold sterile. The product is labeled on the tyvek pouch wit Terminated |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.