510(k) K111194 ยท MNR Ventilatory Effort Recorder
APNEA RISK EVALUATION SYSTEM (ARES)
| Applicant | Advanced Brain Monitoring, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Jul 7, 2011 |
| Received | Apr 28, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111194
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.