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 | K041662 |
| 510k Number | K041662 |
| Device Name: | APNEA RISK EVALUATION SYSTEM (ARES) |
| Classification | Ventilatory Effort Recorder |
| Applicant | ADVANCED BRAIN MONITORING, INC. 2850 PIO PICO DRIVE SUITE A Carlsbad, CA 92008 |
| Contact | Daniel J Levendowski |
| Correspondent | Daniel J Levendowski ADVANCED BRAIN MONITORING, INC. 2850 PIO PICO DRIVE SUITE A Carlsbad, CA 92008 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-18 |
| Decision Date | 2004-10-14 |