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FDA 510(k)

TG-970P CO2 Sensor Kit

K-Number: K161860 · 2017-02-24

ApplicantNihon Kohden Corporation
Decision Date2017-02-24
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

TG-970P CO2 Sensor Kit is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2017-02-24 under 510(k) number K161860. 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 TG-970P CO2 Sensor Kit?

TG-970P CO2 Sensor Kit is a medical device that received FDA 510(k) clearance on 2017-02-24. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K161860.

When did TG-970P CO2 Sensor Kit receive FDA 510(k) clearance?

TG-970P CO2 Sensor Kit received FDA 510(k) clearance on 2017-02-24, under 510(k) number K161860.

Who is the listed applicant for TG-970P CO2 Sensor Kit?

The FDA 510(k) record lists Nihon Kohden Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TG-970P CO2 Sensor Kit?

The FDA product code for TG-970P CO2 Sensor Kit is CCK.

Other records listing Nihon Kohden Corporation 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.

K251641GF-310R Multigas Unit (GF-310R)K260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffK251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)K223567CNS-2101 Central MonitorK220976Life Scope PT BSM-1700 Series Bedside Monitor

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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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