nordicAudio (1.0)— 510(k) K251937
Substantially EquivalentNordicneurolab AS
FDA 510(k) clearance K251937 for nordicAudio (1.0), Substantially Equivalent on 2026-03-20. Applicant: Nordicneurolab AS. Device class: 2.
Summary
Nordicneurolab's nordicAudio (1.0) is filed under LNH, nuclear magnetic resonance imaging systems. The record doesn't describe the product beyond its name and that code name.
Class II, 21 CFR 892.1000. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Nordicneurolab filed from Bergen, Norway. Review took 269 calendar days (June 24, 2025 to March 20, 2026).
Clearance details
- Applicant
- Nordicneurolab AS
- Product code
- Product code LNH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bergen, NO
Recent devices under product code LNH
view allMore clearances from Nordicneurolab AS
view allAdverse events under product code LNH
product code LNH- Death
- 11
- Injury
- 670
- Malfunction
- 1,460
- Other
- 2
- Total
- 2,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.