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FDA 510(k)

FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE

K-Number: K980979 · 1998-06-12

ApplicantFukuda Denshi USA, Inc.
Decision Date1998-06-12
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1998-06-12 under 510(k) number K980979. 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 FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE?

FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE is a medical device that received FDA 510(k) clearance on 1998-06-12. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K980979.

When did FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE receive FDA 510(k) clearance?

FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE received FDA 510(k) clearance on 1998-06-12, under 510(k) number K980979.

Who is the listed applicant for FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE?

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

What is the FDA product code for FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE?

The FDA product code for FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE is CCK.

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Other records listing Fukuda Denshi USA, Inc. as applicant

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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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