The following data is part of a premarket notification filed by Advanced Brain Monitoring, Inc. with the FDA for Apnea Risk Evaluation System (ares).
| Device ID | K112514 |
| 510k Number | K112514 |
| Device Name: | APNEA RISK EVALUATION SYSTEM (ARES) |
| Classification | Ventilatory Effort Recorder |
| Applicant | ADVANCED BRAIN MONITORING, INC. 2511 FOX RIVER CIRCLE Waukesha, WI 53189 |
| Contact | Adrienne Lenz |
| Correspondent | Adrienne Lenz ADVANCED BRAIN MONITORING, INC. 2511 FOX RIVER CIRCLE Waukesha, WI 53189 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-30 |
| Decision Date | 2012-01-09 |
| Summary: | summary |