FDA 510(k)

Maxtec MaxO2 ME+p

K-Number: K221734 · 2023-04-01

Decision Date2023-04-01

Product CodeCCL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Maxtec MaxO2 ME+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 2023-04-01 under 510(k) 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. The listed applicant is Maxtec, LLC. The 510(k) number is K221734.

When did Maxtec MaxO2 ME+p receive FDA 510(k) clearance?

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

Who is the listed applicant for Maxtec MaxO2 ME+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 MaxO2 ME+p?

The FDA product code for Maxtec MaxO2 ME+p 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 K182362MaxCap Ped and MaxCap Neo K161718MaxBlend 2, MaxBlend Lite K153659MaxO2ME

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 K213933Percent Oxygen SensorsCareox, LLC K213948OxyMinderBio-Med Devices, Inc.K173807Accu O2 Oxygen AnalyzerPrecision Medical, 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.