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FDA 510(k)

MAXO2+, MODEL A AND AE

K-Number: K040484 · 2004-06-09

ApplicantMaxtec, Inc.
Decision Date2004-06-09
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MAXO2+, MODEL A AND AE is the device name listed in this FDA 510(k) record. The listed applicant is Maxtec, Inc.. It received FDA 510(k) clearance on 2004-06-09 under 510(k) number K040484. 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 MAXO2+, MODEL A AND AE?

MAXO2+, MODEL A AND AE is a medical device that received FDA 510(k) clearance on 2004-06-09. The listed applicant is Maxtec, Inc.. The 510(k) number is K040484.

When did MAXO2+, MODEL A AND AE receive FDA 510(k) clearance?

MAXO2+, MODEL A AND AE received FDA 510(k) clearance on 2004-06-09, under 510(k) number K040484.

Who is the listed applicant for MAXO2+, MODEL A AND AE?

The FDA 510(k) record lists Maxtec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXO2+, MODEL A AND AE?

The FDA product code for MAXO2+, MODEL A AND AE is CCL.

Related Clinical Trials

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.

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Other records listing Maxtec, Inc. 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.

K113232MAXMIXING BLOCKK063488MAXO2 CU

Related Devices (Code: CCL)

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.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK251245OxyMinder Pro (10310)Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-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.

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