FDA 510(k)

Quality Mix Blender, Oxymixer

K-Number: K221494 · 2023-01-23

Decision Date2023-01-23

Product CodeBZR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Quality Mix Blender, Oxymixer is a medical device manufactured by Dehas Medical Systems GmbH. It received FDA 510(k) clearance on 2023-01-23 under approval number K221494. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Quality Mix Blender, Oxymixer?

Quality Mix Blender, Oxymixer is a medical device that received FDA 510(k) clearance on 2023-01-23. It is manufactured by Dehas Medical Systems GmbH. The 510(k) number is K221494.

When was Quality Mix Blender, Oxymixer approved by the FDA?

Quality Mix Blender, Oxymixer received FDA 510(k) clearance on 2023-01-23, under approval number K221494.

What company makes Quality Mix Blender, Oxymixer?

Quality Mix Blender, Oxymixer is manufactured by Dehas Medical Systems GmbH.

What is the FDA product code for Quality Mix Blender, Oxymixer?

The FDA product code for Quality Mix Blender, Oxymixer is BZR.

Other Devices by Dehas Medical Systems GmbH

K241366QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

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Official Source

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