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FDA 510(k)

Quality Mix Blender, Oxymixer

K-Number: K221494 · 2023-01-23

ApplicantDehas Medical Systems GmbH
Decision Date2023-01-23
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Quality Mix Blender, Oxymixer is the device name listed in this FDA 510(k) record. The listed applicant is Dehas Medical Systems GmbH. It received FDA 510(k) clearance on 2023-01-23 under 510(k) 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. The listed applicant is Dehas Medical Systems GmbH. The 510(k) number is K221494.

When did Quality Mix Blender, Oxymixer receive FDA 510(k) clearance?

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

Who is the listed applicant for Quality Mix Blender, Oxymixer?

The FDA 510(k) record lists Dehas Medical Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Dehas Medical Systems GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: BZR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243917F&P Optiflow Air/Oxygen Flow SourceFisher & Paykel Healthcare, Ltd.K241465Midas Flowmeter; eAVSParker Hannifin CorporationK231895Maxtec MaxBlend2+pMaxtec, LLCK230987FlowStar Analog Mixer FlowmeterBaldus Sedation GmbH & Co. KGK222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KGK202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin

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.

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