Impedance Measuring Device Utilizing Oscillation Techniques
FDA product code PNV · Class II (moderate risk) · 21 CFR 868.1840 · Anesthesiology
This device measures respiratory impedance.
4510(k) clearances
0PMA approvals
0recalls
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K221024 | tremoflo C2 Airwave Oscillometry SystemPNV · Traditional | Thorasys Thoracic Medical Systems, Inc. | 06/20/2023SE |
| K191876 | PulmoScanPNV · Traditional | Cognita Labs, LLC | 03/18/2020SE |
| K170185 | tremoFlo C-100 Airwave Oscillometry SystemPNV · Traditional | Thorasys Thoracic Medical Systems, Inc. | 09/12/2017SE |
| K152585 | Resmon PRO FULLPNV · Traditional | Medical Graphics Corp. | 06/24/2016SE |