Data / Medical devices / Switzerland / Positrigo AG
Positrigo AG: FDA-registered device maker in Zurich, Switzerland, 1 510(k) clearance
Positrigo AG is registered with the FDA (registration 3032577207) in Zurich, Switzerland. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3032577207
- Address
- Technoparkstrasse 1, Zurich, Switzerland, 8005
- Owner or operator
- Positrigo AG (10091382)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
- First device listed
- September 12, 2024
- Registered through
- 2027
- Brand names listed
- NeuroLF (Advanced), NeuroLF (Basic), NeuroLF (Pro), NeuroLF Seat
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Tomography, Computed, Emission | KPS | 2 | Complaint file establishment, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| July 15, 2024 | K241751 | NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat | KPS | Substantially Equivalent | Positrigo AG | accessdata.fda.gov |
Compare with other makers
Updated July 15, 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.