FDA 510(k)

ETCO2 Sensor

K-Number: K171828 · 2018-05-31

Decision Date2018-05-31

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ETCO2 Sensor is a medical device manufactured by Orantech, Inc.. It received FDA 510(k) clearance on 2018-05-31 under approval number K171828. 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 ETCO2 Sensor?

ETCO2 Sensor is a medical device that received FDA 510(k) clearance on 2018-05-31. It is manufactured by Orantech, Inc.. The 510(k) number is K171828.

When was ETCO2 Sensor approved by the FDA?

ETCO2 Sensor received FDA 510(k) clearance on 2018-05-31, under approval number K171828.

What company makes ETCO2 Sensor?

ETCO2 Sensor is manufactured by Orantech, Inc..

What is the FDA product code for ETCO2 Sensor?

The FDA product code for ETCO2 Sensor is CCK.

Other Devices by Orantech, Inc.

K173194Temperature Probe K181270Disposable SpO2 Sensors, Reusable SpO2 Sensors K173197Reusable NIBP Cuff K182327Patient Cables and Leadwires , Disposable ECG Leadwires

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.