510(k) K944833 ยท OMB Automatic Event Detection Software For Full-Montage Electroencephalograph
DIGITRACE SLEEP COMPUTER, SLEEPPAC, HOME SLEEP SYSTEM
| Applicant | New England Medical Monitoring Co., Boston MA, US |
| Decision | Substantially Equivalent, May 4, 1995 |
| Received | Sep 30, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944833
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.