510(k) K080217 ยท OMA Amplitude-Integrated Electroencephalograph
COMPONENT NEUROMONITORING SYSTEM
| Applicant | Moberg Research, Inc., Ambler PA, US |
| Decision | Substantially Equivalent, Nov 5, 2008 |
| Received | Jan 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080217
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2023 | Moberg Research, Inc. Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements
Model: CNS-350 Open, Classified |
OMA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.