PRK — Device Indicating An Exhalation Event Class II
FDA product code PRK covers "Device Indicating An Exhalation Event", a Class II medical device regulated under 21 CFR 868.2375. Submissions are reviewed by the Anesthesiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PRK
- Device Class
- Class II
- Regulation Number
- 868.2375
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
To provide visual indication of each exhalation event
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K161953 | tereopneuma | ReDe Mask | February 17, 2017 |