INFANT MONITOR
Device Facts
| Record ID | K861484 |
|---|---|
| Device Name | INFANT MONITOR |
| Applicant | Healthdyne, Inc. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | May 21, 1986 |
| 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.
