Data / Medical devices / Denmark / Cathvision Aps
Cathvision Aps: FDA-registered device maker in Copenhagen NV Hovedstaden, Denmark, 1 510(k) clearance
Cathvision Aps is registered with the FDA (registration 3017401510) in Copenhagen NV Hovedstaden, Denmark. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 4, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017401510
- Address
- Lygten 37 st. th., Copenhagen NV Hovedstaden, Denmark, 2400
- Owner or operator
- CathVision ApS (10085183)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 15, 2023
- Registered through
- 2026
- Brand names listed
- ECGenius System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 4, 2023 | K223787 | ECGenius System | DQK | Substantially Equivalent | Cath Vision Aps | accessdata.fda.gov |
Compare with other makers
Updated August 4, 2023. 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.