Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K111194
APNEA RISK EVALUATION SYSTEM (ARES) · Advanced Brain Monitoring, Inc. · decided 2011-07-07 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ARES 610 Unicorder System | 610 | Watermark Medical, Inc. | ETN MNR NFB | 00854485007098 |
| ARES 610 Unicorder | 610 | Watermark Medical, Inc. | MNR | 00854485007081 |
| ARES 610 Home Sleep Test Accessories - 10 pack | 610 | Watermark Medical, Inc. | ETN NFB | 00854485007104 |
| ARES 610 Home Sleep Test Accessories - 50 Pack | 610 | Watermark Medical, Inc. | ETN NFB | 00854485007111 |