K191876 is an FDA 510(k) clearance for the PulmoScan. This device is classified as a Impedance Measuring Device Utilizing Oscillation Techniques (Class II - Special Controls, product code PNV).
Submitted by Cognita Labs, LLC (Santa Ana, US). The FDA issued a Cleared decision on March 18, 2020, 247 days after receiving the submission on July 15, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840. This Device Measures Respiratory Impedance..
| 510(k) Number | K191876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2019 |
| Decision Date | March 18, 2020 |
| Days to Decision | 247 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| 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. |