APNOESCREEN PRO, ALPHA SCREEN PRO
Device Facts
| Record ID | K000396 |
|---|---|
| Device Name | APNOESCREEN PRO, ALPHA SCREEN PRO |
| Applicant | Erich Jaeger, Inc. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Dec 27, 2000 |
| 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.
