TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
Device Facts
| Record ID | K884120 |
|---|---|
| Device Name | TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC) |
| Applicant | S & W Medico Teknik |
| Product Code | BZQ · Anesthesiology |
| Decision Date | Jul 17, 1990 |
| 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.
