SNORE SAT RECORDER, MODEL SS41
Device Facts
| Record ID | K002159 |
|---|---|
| Device Name | SNORE SAT RECORDER, MODEL SS41 |
| Applicant | Sagatech Electronics, Inc. |
| Product Code | MNR · Anesthesiology |
| Decision Date | Jun 28, 2002 |
| 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.
