RESPIRATION/APNEA AMPLIFIER MODEL 3105
Device Facts
| Record ID | K792528 |
|---|---|
| Device Name | RESPIRATION/APNEA AMPLIFIER MODEL 3105 |
| Applicant | Electronics For Medicine, Inc. |
| Product Code | BZQ · Anesthesiology |
| Decision Date | Feb 21, 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.
