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FDA 510(k)

ETCO2 Sensor

K-Number: K171828 · 2018-05-31

ApplicantOrantech, Inc.
Decision Date2018-05-31
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ETCO2 Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Orantech, Inc.. It received FDA 510(k) clearance on 2018-05-31 under 510(k) 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. The listed applicant is Orantech, Inc.. The 510(k) number is K171828.

When did ETCO2 Sensor receive FDA 510(k) clearance?

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

Who is the listed applicant for ETCO2 Sensor?

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

What is the FDA product code for ETCO2 Sensor?

The FDA product code for ETCO2 Sensor is CCK.

Other records listing Orantech, 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.

K182327Patient Cables and Leadwires , Disposable ECG LeadwiresK173194Temperature ProbeK181270Disposable SpO2 Sensors, Reusable SpO2 SensorsK173197Reusable NIBP Cuff

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

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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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