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FDA 510(k)

MaxO2ME

K-Number: K153659 · 2016-06-10

ApplicantMaxtec, LLC
Decision Date2016-06-10
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MaxO2ME is a medical device manufactured by Maxtec, LLC. It received FDA 510(k) clearance on 2016-06-10 under approval number K153659. 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 MaxO2ME?

MaxO2ME is a medical device that received FDA 510(k) clearance on 2016-06-10. It is manufactured by Maxtec, LLC. The 510(k) number is K153659.

When was MaxO2ME approved by the FDA?

MaxO2ME received FDA 510(k) clearance on 2016-06-10, under approval number K153659.

What company makes MaxO2ME?

MaxO2ME is manufactured by Maxtec, LLC.

What is the FDA product code for MaxO2ME?

The FDA product code for MaxO2ME is CCL.

Other Devices by Maxtec, LLC

K161718MaxBlend 2, MaxBlend Lite K182362MaxCap Ped and MaxCap Neo K231895Maxtec MaxBlend2+p K221734Maxtec MaxO2 ME+p

Related Devices (Code: CCL)

K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc. K213933Percent Oxygen SensorsCareox, LLC K213948OxyMinderBio-Med Devices, Inc. K221734Maxtec MaxO2 ME+pMaxtec, LLC 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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