Company ยท US
Advanced Brain Monitoring, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2018. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 2018 | K172799 | Positional Sleep Assessment System (PoSAS) software Advanced Brain Monitoring | MNR |
| Mar 14, 2016 | K153412 | Sleep Profiler Advanced Brain Monitoring, Inc. | OLZ |
| Oct 30, 2015 | K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) Advanced Brain Monitoring, Inc. | OMC |
| May 29, 2014 | K140190 | NIGHT SHIFT Advanced Brain Monitoring, Inc. | MYB |
| Nov 27, 2013 | K131383 | X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE Advanced Brain Monitoring, Inc. | GWQ |
| Apr 17, 2013 | K130007 | SLEEP PROFILER Advanced Brain Monitoring, Inc. | OLZ |
| Jan 31, 2013 | K130013 | X4 SYSTEM Advanced Brain Monitoring, Inc. | OMC |
| Sep 19, 2012 | K120450 | SLEEP PROFILER Advanced Brain Monitoring, Inc. | OLZ |
| Jun 20, 2012 | K120447 | X4 Advanced Brain Monitoring, Inc. | OMC |
| Jan 9, 2012 | K112514 | APNEA RISK EVALUATION SYSTEM (ARES) Advanced Brain Monitoring, Inc. | MNR |
| Jul 22, 2011 | K111110 | APNEA GUARD Advanced Brain Monitoring, Inc. | LRK |
| Jul 7, 2011 | K111194 | APNEA RISK EVALUATION SYSTEM (ARES) Advanced Brain Monitoring, Inc. | MNR |
| Apr 14, 2011 | K110705 | APNEA RISK EVALUATION SYSTEM (ARES) Advanced Brain Monitoring, Inc. | MNR |
| Oct 3, 2007 | K071230 | APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 Advanced Brain Monitoring, Inc. | MNR |
| Oct 14, 2004 | K041662 | APNEA RISK EVALUATION SYSTEM (ARES) Advanced Brain Monitoring, Inc. | MNR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||