SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM
Device Facts
| Record ID | K904396 |
|---|---|
| Device Name | SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM |
| Applicant | Simplex Medical Systems, Inc. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | Mar 5, 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.
