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FDA 510(k)

CARBON DIOXIDE MONITOR, MODEL OLG-2800A

K-Number: K062115 · 2006-12-27

ApplicantNihon Kohden America, Inc.
Decision Date2006-12-27
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CARBON DIOXIDE MONITOR, MODEL OLG-2800A is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 2006-12-27 under 510(k) number K062115. 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 CARBON DIOXIDE MONITOR, MODEL OLG-2800A?

CARBON DIOXIDE MONITOR, MODEL OLG-2800A is a medical device that received FDA 510(k) clearance on 2006-12-27. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K062115.

When did CARBON DIOXIDE MONITOR, MODEL OLG-2800A receive FDA 510(k) clearance?

CARBON DIOXIDE MONITOR, MODEL OLG-2800A received FDA 510(k) clearance on 2006-12-27, under 510(k) number K062115.

Who is the listed applicant for CARBON DIOXIDE MONITOR, MODEL OLG-2800A?

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

What is the FDA product code for CARBON DIOXIDE MONITOR, MODEL OLG-2800A?

The FDA product code for CARBON DIOXIDE MONITOR, MODEL OLG-2800A is CCK.

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Other records listing Nihon Kohden America, 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.

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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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