PRK · Device Indicating An Exhalation Event
Anesthesiology · 21 CFR 868.2375 · Class 2
Overview
| Product Code | PRK |
|---|---|
| Device Name | Device Indicating An Exhalation Event |
| Regulation | 21 CFR 868.2375 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161953 | ReDe Mask | Tereopneuma | Feb 17, 2017 | SESE |
Top Applicants
- Tereopneuma — 1 clearance
