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FDA 510(k)

MaxCap Ped and MaxCap Neo

K-Number: K182362 · 2019-05-23

ApplicantMaxtec, LLC
Decision Date2019-05-23
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MaxCap Ped and MaxCap Neo is the device name listed in this FDA 510(k) record. The listed applicant is Maxtec, LLC. It received FDA 510(k) clearance on 2019-05-23 under 510(k) number K182362. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MaxCap Ped and MaxCap Neo?

MaxCap Ped and MaxCap Neo is a medical device that received FDA 510(k) clearance on 2019-05-23. The listed applicant is Maxtec, LLC. The 510(k) number is K182362.

When did MaxCap Ped and MaxCap Neo receive FDA 510(k) clearance?

MaxCap Ped and MaxCap Neo received FDA 510(k) clearance on 2019-05-23, under 510(k) number K182362.

Who is the listed applicant for MaxCap Ped and MaxCap Neo?

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 MaxCap Ped and MaxCap Neo?

The FDA product code for MaxCap Ped and MaxCap Neo is CCK.

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+pK221734Maxtec MaxO2 ME+pK161718MaxBlend 2, MaxBlend LiteK153659MaxO2ME

Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, Inc.

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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