510(k) K071984 ยท GWM Device, Monitoring, Intracranial Pressure
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
| Applicant | Cma Microdialysis AB, North Chelmsford MA, US |
| Decision | Substantially Equivalent, Jun 27, 2008 |
| Received | Jul 19, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071984
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.