VMA PEDIATRIC APNEA MATTRESS
Device Facts
| Record ID | K811865 |
|---|---|
| Device Name | VMA PEDIATRIC APNEA MATTRESS |
| Applicant | Vickers America Medical Corp. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | Jul 31, 1981 |
| 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.
