Data / Medical devices / Netherlands / NICo-Lab B.V.
NICo-Lab B.V.: FDA-registered device maker in Amsterdam Noord-Holland, Netherlands, 3 510(k) clearances
NICo-Lab B.V. is registered with the FDA (registration 3021915828) in Amsterdam Noord-Holland, Netherlands. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 14, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021915828
- Address
- Paasheuvelweg 25, Amsterdam Noord-Holland, Netherlands, 1105 BP
- Owner or operator
- NICo-lab B.V. (10084560)
- Roles
- Manufacturer
- First device listed
- March 7, 2022
- Registered through
- 2026
- Brand names listed
- StrokeViewer LVO Triaging, StrokeViewer Perfusion
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Radiological Computer-Assisted Triage And Notification Software | QAS | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 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 14, 2023 | K231570 | StrokeViewer Perfusion | LLZ | Substantially Equivalent | Nico-Lab B.V. | accessdata.fda.gov |
| July 8, 2021 | K211788 | HALO | QAS | Substantially Equivalent | Nicolab B.V. | accessdata.fda.gov |
| November 20, 2020 | K200873 | HALO | QAS | Substantially Equivalent | Nico-Lab B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Radiological Computer-Assisted Triage And Notification Software
Updated December 14, 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.