Model TPC-1 Oxygen Analyzer

FDA 510(k) K821392 · Marathon

Substantially Equivalent

510(k) numberK821392

Submission

Device name
Model TPC-1 Oxygen Analyzer
Applicant
Marathon
Mchenry, IL, US
Received
May 11, 1982
Decision date
July 8, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
CCL – Analyzer, Gas, Oxygen, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1720
Specialty
Anesthesiology

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K250002Smart Check O2 (MA0236)CCL · Traditional Life Spark Medical, LLC04/24/2025SE
K221734Maxtec MaxO2 ME+pCCL · Traditional Maxtec, LLC04/01/2023SE
K213933Percent Oxygen SensorsCCL · Traditional Careox, LLC08/19/2022SE
K213948OxyMinderCCL · Traditional Bio-Med Devices, Inc.03/17/2022SE
K173807Accu O2 Oxygen AnalyzerCCL · Abbreviated Precision Medical, Inc.05/02/2018SE
K153659MaxO2MECCL · Traditional Maxtec, LLC06/10/2016SE
K123195Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and AccessoriesCCL · Traditional GE Healthcare Finland Oy02/28/2013SE
K122290Envitec Mysign O Oxygen Measuring DeviceCCL · Traditional Envitec-Wismar GmbH01/23/2013SE

More from Envitec-Wismar GmbH

510(k)DeviceDecision
K821393System One Oxygen ConcentratorCAW · Traditional 08/10/1982SE
K821520Model 379 Flow/DividerCAW · Traditional 06/02/1982SE

Questions and answers

When was Model TPC-1 Oxygen Analyzer cleared by the FDA?

Model TPC-1 Oxygen Analyzer (K821392) received a 510(k) decision of Substantially Equivalent on July 8, 1982, 58 days after the submission was received.

What is the product code of K821392?

The FDA product code is CCL – Analyzer, Gas, Oxygen, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1720.