PRK
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device Indicating An Exhalation Event
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- FDA definition
- To provide visual indication of each exhalation event
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ReDe Mask (K161953) | Tereopneuma | 2017-02-17 |
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