K211135 is an FDA 510(k) clearance for the Enlight 2100. This device is classified as a Ventilatory Electrical Impedance Tomograph (Class II - Special Controls, product code QEB).
Submitted by Timpel S.A. (Sao Paulo, BR). The FDA issued a Cleared decision on January 6, 2022, 265 days after receiving the submission on April 16, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1505. A Ventilatory Electrical Impedance Tomograph Is A Prescription Non-invasive, Non-radiological Ventilatory Device That Provides An Assessment Of Local Impedance Variation Within A Cross-section Of A Patient?s Thorax..
| 510(k) Number | K211135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 2021 |
| Decision Date | January 06, 2022 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | QEB — Ventilatory Electrical Impedance Tomograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1505 |
| Definition | A Ventilatory Electrical Impedance Tomograph Is A Prescription Non-invasive, Non-radiological Ventilatory Device That Provides An Assessment Of Local Impedance Variation Within A Cross-section Of A Patient?s Thorax. |