Data / Medical devices / Denmark / Cortex Technology Aps
Cortex Technology Aps: FDA-registered device maker in Aalborg Nordjylland, Denmark, 2 510(k) clearances
Cortex Technology Aps is registered with the FDA (registration 9613249) in Aalborg Nordjylland, Denmark. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 17, 1999. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613249
- FEI number
- 3002987034
- Address
- Niels Jernes vej 6B, Aalborg Nordjylland, Denmark, 9220
- Owner or operator
- CORTEX TECHNOLOGY APS (9034314)
- Roles
- Manufacturer
- First device listed
- November 6, 2007
- Registered through
- 2026
- Brand names listed
- CryoPro Maxi, CryoPro Mini, DermaScan C Ultrasonic System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 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 |
|---|---|---|---|---|---|---|
| March 17, 1999 | K983945 | CORTEX DERMASCAN C ULTRASONIC SYSTEM | IYO | Substantially Equivalent | Cortex Technology Aps | accessdata.fda.gov |
| November 25, 1998 | K982280 | CRYOPRO MAXI AND CRYOPRO MINI | GEH | Substantially Equivalent | Cortex Technology Aps | accessdata.fda.gov |
Compare with other makers
Updated March 17, 1999. 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.