510(k) K112514 ยท MNR Ventilatory Effort Recorder
APNEA RISK EVALUATION SYSTEM (ARES)
| Applicant | Advanced Brain Monitoring, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Jan 9, 2012 |
| Received | Aug 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112514
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.