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FDA 510(k)

Maxtec MaxO2 ME+p

K-Number: K221734 · 2023-04-01

ApplicantMaxtec, LLC
Decision Date2023-04-01
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Maxtec MaxO2 ME+p is a medical device manufactured by Maxtec, LLC. It received FDA 510(k) clearance on 2023-04-01 under approval number K221734. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Maxtec MaxO2 ME+p?

Maxtec MaxO2 ME+p is a medical device that received FDA 510(k) clearance on 2023-04-01. It is manufactured by Maxtec, LLC. The 510(k) number is K221734.

When was Maxtec MaxO2 ME+p approved by the FDA?

Maxtec MaxO2 ME+p received FDA 510(k) clearance on 2023-04-01, under approval number K221734.

What company makes Maxtec MaxO2 ME+p?

Maxtec MaxO2 ME+p is manufactured by Maxtec, LLC.

What is the FDA product code for Maxtec MaxO2 ME+p?

The FDA product code for Maxtec MaxO2 ME+p is CCL.

Other Devices by Maxtec, LLC

K161718MaxBlend 2, MaxBlend Lite K153659MaxO2ME K182362MaxCap Ped and MaxCap Neo K231895Maxtec MaxBlend2+p

Related Devices (Code: CCL)

K153659MaxO2MEMaxtec, LLC K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc. K213933Percent Oxygen SensorsCareox, LLC K213948OxyMinderBio-Med Devices, Inc. K251245OxyMinder Pro (10310)Bio-Med Device, Inc. K250002Smart Check O2 (MA0236)Life Spark Medical, LLC

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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