Transparency Registry · applicant

Nico-Lab B.V.: 1 FDA AI clearance

Every 510(k) clearance held by Nico-Lab B.V. under the AI-associated product codes this registry tracks, from openFDA public records, refreshed weekly. Facts only; listing is not evaluation.

Device	Decision date	Category
HALO	2020-11-20	QAS

Sources linked on each entry. Coverage note: this lists clearances under tracked AI-associated codes only — the company may hold other clearances outside them. Work for Nico-Lab B.V.? The disclosure rows on your entries update free on submission of public links — start here.

Link to this page. Many companies reference their registry listing from press pages and footers — it is a neutral, weekly-verified public record. Copy either snippet:

Text link:

<a href="https://healthcareaiops.com/registry/company/nico-lab-b-v/">Nico-Lab B.V. — FDA AI clearances, verified in the Healthcare AI Transparency Registry</a>

Badge:

<a href="https://healthcareaiops.com/registry/company/nico-lab-b-v/" style="display:inline-block;border:1px solid #E3E5E8;border-left:3px solid #0F62FE;padding:6px 12px;font:600 12px sans-serif;color:#16191D;text-decoration:none">✓ 1 FDA AI clearance · Transparency Registry</a>