RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
Device Facts
| Record ID | K903020 |
|---|---|
| Device Name | RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 |
| Applicant | Aequitron Medical, Inc. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | Apr 10, 1991 |
| 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.
