510(k) K910771 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
DIGITRACE(TM) HOME MONIT COMP/ELB(TM) EEG LUNCH BX
| Applicant | New England Medical Instruments, Inc., Lexington MA, US |
| Decision | Substantially Equivalent, Dec 18, 1991 |
| Received | Feb 22, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910771
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.