Data / Medical devices / Ventilatory Electrical Impedance Tomograph
Ventilatory Electrical Impedance Tomograph (QEB): 4 FDA-registered makers in 3 countries
4 establishments in 3 countries are registered with the FDA to make Ventilatory Electrical Impedance Tomograph (product code QEB, Class 2, 21 CFR 868.1505). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on September 10, 2025, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QEB
- Device class
- 2
- Regulation
- 868.1505
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| Brazil | 2 |
| Switzerland | 1 |
| United States | 1 |
Makers of Ventilatory Electrical Impedance Tomograph
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Timpel S.A. | Sao Paulo, Brazil | Manufacturer, Specification developer | 3 | September 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Timpel S.A. | Pato Branco Parana, Brazil | Manufacturer | 3 | September 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sentec AG | THERWIL Basel-Landschaft, Switzerland | Manufacturer | 1 | August 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| Percussionaire Corp. | Sandpoint, ID, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.