Ventilatory Electrical Impedance Tomograph
Device Code: 207
Product Code(s):
QEB 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.
Device Classification Information
| Device Type ID | 207 |
| Device Name | Ventilatory Electrical Impedance Tomograph |
| Physical State | Electrodes, Belt, Plethysmogram. |
| Technical Method | Electrical Impedance Tomography Is Used To Provide Information Of Local Impedance Variation Within A Cross-section Of A Patient's Thorax. |
| Target Area | Thorax |
| Regulation Medical Specialty | Anesthesiology |
| Review Panel | Anesthesiology |
| Submission Type | 510(k) |
| CFR Regulation Number | 868.1505 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QEB |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 207 |
| Device | Ventilatory Electrical Impedance Tomograph |
| Product Code | QEB |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 868.1505 [🔎] |
TPLC Last Update: 2019-04-02 19:30:36