510(k) K102077 ยท GWM Device, Monitoring, Intracranial Pressure
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
| Applicant | Cma Microdialysis AB, North Chelmsford MA, US |
| Decision | Substantially Equivalent, Jan 14, 2011 |
| Received | Jul 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102077
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.