APNEA RISK EVALUATION SYSTEM (ARES)
Device Facts
| Record ID | K041662 |
|---|---|
| Device Name | APNEA RISK EVALUATION SYSTEM (ARES) |
| Applicant | Advanced Brain Monitoring, Inc. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Oct 14, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.
