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FDA 510(k)

Maxtec MaxBlend2+p

K-Number: K231895 · 2023-12-04

ApplicantMaxtec, LLC
Decision Date2023-12-04
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Maxtec MaxBlend2+p is the device name listed in this FDA 510(k) record. The listed applicant is Maxtec, LLC. It received FDA 510(k) clearance on 2023-12-04 under 510(k) number K231895. 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 Maxtec MaxBlend2+p?

Maxtec MaxBlend2+p is a medical device that received FDA 510(k) clearance on 2023-12-04. The listed applicant is Maxtec, LLC. The 510(k) number is K231895.

When did Maxtec MaxBlend2+p receive FDA 510(k) clearance?

Maxtec MaxBlend2+p received FDA 510(k) clearance on 2023-12-04, under 510(k) number K231895.

Who is the listed applicant for Maxtec MaxBlend2+p?

The FDA 510(k) record lists Maxtec, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Maxtec MaxBlend2+p?

The FDA product code for Maxtec MaxBlend2+p is BZR.

Other records listing Maxtec, LLC 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.

K221734Maxtec MaxO2 ME+pK182362MaxCap Ped and MaxCap NeoK161718MaxBlend 2, MaxBlend LiteK153659MaxO2ME

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 CorporationK230987FlowStar Analog Mixer FlowmeterBaldus Sedation GmbH & Co. KGK222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KGK221494Quality Mix Blender, OxymixerDehas Medical Systems GmbHK202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin

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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