PNV — Impedance Measuring Device Utilizing Oscillation Techniques Class II
FDA product code PNV covers "Impedance Measuring Device Utilizing Oscillation Techniques", a Class II medical device regulated under 21 CFR 868.1840. Submissions are reviewed by the Anesthesiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PNV
- Device Class
- Class II
- Regulation Number
- 868.1840
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Definition
This device measures respiratory impedance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K221024 | thorasys thoracic medical systems | tremoflo C2 Airwave Oscillometry System | June 20, 2023 |
| K191876 | cognita labs | PulmoScan | March 18, 2020 |
| K170185 | thorasys thoracic medical systems | tremoFlo C-100 Airwave Oscillometry System | September 12, 2017 |
| K152585 | medical graphics | Resmon PRO FULL | June 24, 2016 |