Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

°M Warmer System

K-Number: K232107 · 2024-05-31

ApplicantMequ A/S
Decision Date2024-05-31
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

°M Warmer System is a medical device manufactured by Mequ A/S. It received FDA 510(k) clearance on 2024-05-31 under approval number K232107. 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?

°M Warmer System is a medical device that received FDA 510(k) clearance on 2024-05-31. It is manufactured by Mequ A/S. The 510(k) number is K232107.

When was °M Warmer System approved by the FDA?

°M Warmer System received FDA 510(k) clearance on 2024-05-31, under approval number K232107.

What company makes °M Warmer System?

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

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

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

Other Devices by Mequ A/S

K260988°M Warmer System with °M Station

Related Devices (Code: LGZ)

K161613Hang&Go PACRand S.R.L. K150404QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K171215QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K163708QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K180154QiF Blood and Fluid WarmerQuality IN Flow , Ltd. K192325Quantum Blood and Fluid Warming SystemLife Warmer, Inc.

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.

↑