510(k) K001980 ยท GXY Electrode, Cutaneous
ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0110
| Applicant | Aspect Medical Systems, Inc., Newton MA, US |
| Decision | Substantially Equivalent, Sep 27, 2000 |
| Received | Jun 29, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001980
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.