FDA 510(k)

MaxO2ME

K-Number: K153659 · 2016-06-10

Decision Date2016-06-10

Product CodeCCL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MaxO2ME is the device name listed in this FDA 510(k) record. The listed applicant is Maxtec, LLC. It received FDA 510(k) clearance on 2016-06-10 under 510(k) 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. The listed applicant is Maxtec, LLC. The 510(k) number is K153659.

When did MaxO2ME receive FDA 510(k) clearance?

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

Who is the listed applicant for MaxO2ME?

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 MaxO2ME?

The FDA product code for MaxO2ME is CCL.

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

Related Devices (Code: CCL)

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter Labs K251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLC K221734Maxtec MaxO2 ME+pMaxtec, LLC K213933Percent Oxygen SensorsCareox, LLC K213948OxyMinderBio-Med Devices, Inc.

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.