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Monitor, Patient, Resp. Carbon Dioxide

by Cavitron Corp.

510(k) K770713

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK770713 Date27 Apr 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CCK
Device Class
Class II
Regulation
21 CFR Part 868.1400
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

The device is manufactured by Cavitron Corp. and was FDA 510(k) cleared on April 27, 1977 with product code CCK. It is intended for use in anesthesiology settings. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions is provided in the data.

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See all devices from Cavitron Corp. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the purpose of the Patient Respiratory Carbon Dioxide Monitor?

    This device is designed to measure the concentration of carbon dioxide in gas mixtures to help determine a patient's ventilatory, circulatory, and metabolic status during medical procedures, particularly in anesthesiology settings.

  • How is the Patient Respiratory Carbon Dioxide Monitor supplied?

    The device data does not specify information regarding sterility, single-use or reusable status, sizes, or storage conditions. The manufacturer is Cavitron Corp., and it was FDA 510(k) cleared on April 27, 1977.

  • What measurement techniques does this carbon dioxide analyzer use?

    The device may utilize various techniques to measure carbon dioxide concentration, including chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry, depending on the specific model configuration.

  • What is the regulatory status of this device?

    The Patient Respiratory Carbon Dioxide Monitor has FDA 510(k) clearance with product code CCK, granted on April 27, 1977. It was determined to be substantially equivalent to predicate devices for use in anesthesiology settings.