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FDA 510(k)

°M Warmer System with °M Station

K-Number: K260988 · 2026-04-24

ApplicantMequ A/S
Decision Date2026-04-24
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

°M Warmer System with °M Station is a medical device manufactured by Mequ A/S. It received FDA 510(k) clearance on 2026-04-24 under approval number K260988. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the °M Warmer System with °M Station?

°M Warmer System with °M Station is a medical device that received FDA 510(k) clearance on 2026-04-24. It is manufactured by Mequ A/S. The 510(k) number is K260988.

When was °M Warmer System with °M Station approved by the FDA?

°M Warmer System with °M Station received FDA 510(k) clearance on 2026-04-24, under approval number K260988.

What company makes °M Warmer System with °M Station?

°M Warmer System with °M Station is manufactured by Mequ A/S.

What is the FDA product code for °M Warmer System with °M Station?

The FDA product code for °M Warmer System with °M Station is LGZ.

Other Devices by Mequ A/S

K232107°M Warmer System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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