K180011 is an FDA 510(k) clearance for the Pulmonx Chartis Tablet Console. This device is classified as a Spirometer, Diagnostic (Class II - Special Controls, product code BZG).
Submitted by Pulmonx Corporation (Redwood City, US). The FDA issued a Cleared decision on July 13, 2018, 192 days after receiving the submission on January 2, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1840.
| 510(k) Number | K180011 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 2018 |
| Decision Date | July 13, 2018 |
| Days to Decision | 192 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BZG - Spirometer, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1840 |