ULTIMA SMARTBELT, MODEL 0560
Device Facts
| Record ID | K001743 |
|---|---|
| Device Name | ULTIMA SMARTBELT, MODEL 0560 |
| Applicant | Braebon Medical Corp. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | Aug 25, 2000 |
| Decision | SESE |
| Submission Type | Special |
| 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.
