Data / Medical devices / Croatia / Pamel D.O.O.
Pamel D.O.O.: FDA-registered device maker in Zagreb Zagreb, Grad, Croatia, 1 510(k) clearance
Pamel D.O.O. is registered with the FDA (registration 3021192567) in Zagreb Zagreb, Grad, Croatia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 9, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021192567
- Address
- Dubravica 41f, Zagreb Zagreb, Grad, Croatia, 10090
- Owner or operator
- Pamel d.o.o. (10083725)
- Roles
- Manufacturer
- First device listed
- December 14, 2021
- Registered through
- 2026
- Brand names listed
- COMBY EEG CAP, COMBY EEG CAP ACCESSORIE, EEG ELECTRODE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 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 |
|---|---|---|---|---|---|---|
| November 9, 2021 | K211315 | Comby EEG Caps | GXY | Substantially Equivalent | Pamel D.O.O | accessdata.fda.gov |
Compare with other makers
Updated November 9, 2021. 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.