K221024 is an FDA 510(k) clearance for the tremoflo C2 Airwave Oscillometry System. This device is classified as a Impedance Measuring Device Utilizing Oscillation Techniques (Class II - Special Controls, product code PNV).
Submitted by Thorasys Thoracic Medical Systems, Inc. (Montreal, CA). The FDA issued a Cleared decision on June 20, 2023, 440 days after receiving the submission on April 6, 2022.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840. This Device Measures Respiratory Impedance..
| 510(k) Number | K221024 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2022 |
| Decision Date | June 20, 2023 |
| Days to Decision | 440 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | PNV — Impedance Measuring Device Utilizing Oscillation Techniques |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |
| Definition | This Device Measures Respiratory Impedance. |