Data / Medical devices / Germany / Thora Tech GmbH
Thora Tech GmbH: FDA-registered device maker in Giesen Lower Saxony, Germany, 1 510(k) clearance
Thora Tech GmbH is registered with the FDA (registration 3016450067) in Giesen Lower Saxony, Germany. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 20, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016450067
- Address
- Gutfleischstr. 3-5, Giesen Lower Saxony, Germany, 35390
- Owner or operator
- Thora Tech GmbH (10087914)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 28, 2023
- Registered through
- 2026
- Brand names listed
- LaserJet Catheter, Monsoon Critical Care Jet Ventilator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 20, 2002 | K012691 | MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES | CBK | Substantially Equivalent | Acutronic Medical Systems AG | accessdata.fda.gov |
Compare with other makers
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Ventilator, Continuous, Facility Use
Updated December 20, 2002. 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.