510(k) K180421 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
Natus NeuroWorks
| Applicant | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek), Oakville, CA |
| Decision | Substantially Equivalent, Mar 14, 2018 |
| Received | Feb 16, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180421
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.