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FDA 510(k)

DYNEX CO2/2000, CO2 ANALYZER

K-Number: K862543 · 1986-07-15

ApplicantAnalytical Products, Inc.
Decision Date1986-07-15
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DYNEX CO2/2000, CO2 ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Products, Inc.. It received FDA 510(k) clearance on 1986-07-15 under 510(k) number K862543. 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 DYNEX CO2/2000, CO2 ANALYZER?

DYNEX CO2/2000, CO2 ANALYZER is a medical device that received FDA 510(k) clearance on 1986-07-15. The listed applicant is Analytical Products, Inc.. The 510(k) number is K862543.

When did DYNEX CO2/2000, CO2 ANALYZER receive FDA 510(k) clearance?

DYNEX CO2/2000, CO2 ANALYZER received FDA 510(k) clearance on 1986-07-15, under 510(k) number K862543.

Who is the listed applicant for DYNEX CO2/2000, CO2 ANALYZER?

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

What is the FDA product code for DYNEX CO2/2000, CO2 ANALYZER?

The FDA product code for DYNEX CO2/2000, CO2 ANALYZER is CCK.

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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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