MONAGHAN RVM, MODEL 760 AND 761
Device Facts
| Record ID | K863612 |
|---|---|
| Device Name | MONAGHAN RVM, MODEL 760 AND 761 |
| Applicant | Monaghan Medical Corp. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | Oct 15, 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.
