FDA 510(k)

MaxCap Ped and MaxCap Neo

K-Number: K182362 · 2019-05-23

Decision Date2019-05-23

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

MaxCap Ped and MaxCap Neo is a medical device manufactured by Maxtec, LLC. It received FDA 510(k) clearance on 2019-05-23 under approval 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. It is manufactured by Maxtec, LLC. The 510(k) number is K182362.

When was MaxCap Ped and MaxCap Neo approved by the FDA?

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

What company makes MaxCap Ped and MaxCap Neo?

MaxCap Ped and MaxCap Neo is manufactured by Maxtec, LLC.

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 Devices by Maxtec, LLC

K161718MaxBlend 2, MaxBlend Lite K153659MaxO2ME K231895Maxtec MaxBlend2+p K221734Maxtec MaxO2 ME+p

Related Devices (Code: CCK)

K162343Westmed Gas Sampling Cannula with O2 deliveryWestmed, Inc. K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH K171765Nihon Kohden CO2 MonitorNihon Kohden Corporation K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesGE Healthcare Finland Oy K161250OC-FLEX Flexible IntraOral CannulaVenture Therapeutics, 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.