K170185 is an FDA 510(k) clearance for the tremoFlo C-100 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 September 12, 2017, 232 days after receiving the submission on January 23, 2017.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840. This Device Measures Respiratory Impedance..
| 510(k) Number | K170185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2017 |
| Decision Date | September 12, 2017 |
| Days to Decision | 232 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. |