510(k) K013863 ยท OMC Reduced- Montage Standard Electroencephalograph
CRYSTAL MONITOR MODEL 16
| Applicant | Cleveland Medical Devices, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 19, 2002 |
| Received | Nov 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013863
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.