Data / Medical devices / Germany / Ganshorn Medizin Electronic GMBH
Ganshorn Medizin Electronic GMBH: FDA-registered device maker in Bad Neustadt Bavaria, Germany, 2 510(k) clearances
Ganshorn Medizin Electronic GMBH is registered with the FDA (registration 3006419626) in Bad Neustadt Bavaria, Germany. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 9, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006419626
- Address
- Theodor-Jopp-Str. 2, Bad Neustadt Bavaria, Germany, 97616
- Owner or operator
- GANSHORN Medizin Electronic GmbH (10054030)
- Roles
- Manufacturer
- First device listed
- February 3, 2017
- Registered through
- 2026
- Brand names listed
- PowerCube Body+, PowerCube Body+ / Diffusion+, PowerCube Diffusion+, PowerCube+ Series, ScoutTube, SpiroDef, SpiroScout, SpiroScout SP and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Mouthpiece, Breathing | BYP | 1 | Manufacturer | accessdata.fda.gov |
| Plethysmograph, Volume | JEH | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Manufacturer | 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 9, 2024 | K240706 | PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) | JEH | Substantially Equivalent | Ganshorn Medizin Electronic GmbH | accessdata.fda.gov |
| October 7, 2016 | K160116 | SpiroScout | BZG | Substantially Equivalent | Ganshorn Medizin Electronic GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Spirometer, Diagnostic
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Plethysmograph, Volume
- All makers of Mouthpiece, Breathing
Updated December 9, 2024. 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.