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Model TPC-1 Oxygen Analyzer

by Marathon 510(k)

Active United States

510(k) K821392

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821392 Date8 Jul 1982ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CCL
Device Class
Class II
Regulation
21 CFR Part 868.1720
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

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

An analyzer, gas, oxygen, gaseous-phase is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This device is classified under product code CCL and regulation number 868.1720.

It is a class II device cleared via the FDA 510(k) pathway under K821392, with a substantially equivalent decision dated July 8, 1982. The device is manufactured by Marathon and is intended for use in anesthesiology settings.

Other devices from Marathon

Questions

AI-generated answers, 24 Sep 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 MODEL TPC-1 OXYGEN ANALYZER used for?

    The MODEL TPC-1 OXYGEN ANALYZER is intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography, and is designed for use in anesthesiology settings.

  • How is the MODEL TPC-1 OXYGEN ANALYZER supplied or configured for use?

    The device is supplied as a standalone analyzer unit intended for integration into respiratory gas monitoring systems in clinical environments, specifically for anesthesiology applications, based on its classification and intended use.

  • Is the MODEL TPC-1 OXYGEN ANALYZER reusable or single-use?

    The MODEL TPC-1 OXYGEN ANALYZER is a reusable medical device, as it is an analyzer instrument designed for repeated use in clinical settings after appropriate cleaning and maintenance, not a consumable or single-use sensor.