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FDA 510(k)

MaxBlend 2, MaxBlend Lite

K-Number: K161718 · 2016-10-27

ApplicantMaxtec, LLC
Decision Date2016-10-27
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MaxBlend 2, MaxBlend Lite is the device name listed in this FDA 510(k) record. The listed applicant is Maxtec, LLC. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K161718. 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 MaxBlend 2, MaxBlend Lite?

MaxBlend 2, MaxBlend Lite is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Maxtec, LLC. The 510(k) number is K161718.

When did MaxBlend 2, MaxBlend Lite receive FDA 510(k) clearance?

MaxBlend 2, MaxBlend Lite received FDA 510(k) clearance on 2016-10-27, under 510(k) number K161718.

Who is the listed applicant for MaxBlend 2, MaxBlend Lite?

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 MaxBlend 2, MaxBlend Lite?

The FDA product code for MaxBlend 2, MaxBlend Lite 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.

K231895Maxtec MaxBlend2+pK221734Maxtec MaxO2 ME+pK182362MaxCap Ped and MaxCap NeoK153659MaxO2ME

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. KGK221494Quality Mix Blender, OxymixerDehas Medical Systems GmbH

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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