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FDA 510(k)

PRE-CHECK C02 DETECTOR

K-Number: K861398 · 1986-05-06

ApplicantAlleghany Intl. Medical Technology
Decision Date1986-05-06
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRE-CHECK C02 DETECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Alleghany Intl. Medical Technology. It received FDA 510(k) clearance on 1986-05-06 under 510(k) number K861398. 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 PRE-CHECK C02 DETECTOR?

PRE-CHECK C02 DETECTOR is a medical device that received FDA 510(k) clearance on 1986-05-06. The listed applicant is Alleghany Intl. Medical Technology. The 510(k) number is K861398.

When did PRE-CHECK C02 DETECTOR receive FDA 510(k) clearance?

PRE-CHECK C02 DETECTOR received FDA 510(k) clearance on 1986-05-06, under 510(k) number K861398.

Who is the listed applicant for PRE-CHECK C02 DETECTOR?

The FDA 510(k) record lists Alleghany Intl. Medical Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRE-CHECK C02 DETECTOR?

The FDA product code for PRE-CHECK C02 DETECTOR is CCK.

Related Clinical Trials

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Other records listing Alleghany Intl. Medical Technology 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.

K862880SARA RTK852062SARACAP RESPIRATORY MONITOR

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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