The following data is part of a premarket notification filed by Advanced Brain Monitoring, Inc. with the FDA for Apnea Risk Evaluation System (ares), Model 600.
| Device ID | K071230 |
| 510k Number | K071230 |
| Device Name: | APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 |
| Classification | Ventilatory Effort Recorder |
| Applicant | ADVANCED BRAIN MONITORING, INC. 2237 FARADAY AVENUE SUITE 100 Carlsbad, CA 92008 |
| Contact | Daniel J Levendowski |
| Correspondent | Daniel J Levendowski ADVANCED BRAIN MONITORING, INC. 2237 FARADAY AVENUE SUITE 100 Carlsbad, CA 92008 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-03 |
| Decision Date | 2007-10-03 |
| Summary: | summary |