°M Warmer System with °M Station— 510(k) K260988

Substantially Equivalent

Mequ A/S

FDA 510(k) clearance K260988 for °M Warmer System with °M Station, Substantially Equivalent on 2026-04-24. Applicant: Mequ A/S.

Clearance details

Applicant: Mequ A/S
Product code: Code LGZ
Advisory panel: General Hospital
Date received: 2026-03-25
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Copenhagen/Kobenhavn, DK

Download summary PDF View on FDA.gov ↗

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.