PDS MODEL 3000 ADULT RESPIRATION MODULE
Device Facts
| Record ID | K802046 |
|---|---|
| Device Name | PDS MODEL 3000 ADULT RESPIRATION MODULE |
| Applicant | General Electric Co. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | Sep 16, 1980 |
| 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.
