What is the primary function of the Et Control software option?

The primary function of the Et Control software option is to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that they set during an anesthetic procedure. It does this by making multiple, limited adjustments to the fresh gas composition and total flow.

Which anesthesia system is compatible with the Et Control feature?

The Et Control feature is indicated for use with the Datex-Ohmeda Aisys CS2 anesthesia system. It is a software option that is integrated into this specific system to perform its function.

Is the Et Control feature intended for all patients undergoing anesthesia?

No, the Et Control feature is indicated for patients 18 years of age and older. It is intended for prescription use only and is part of the Aisys CS2 anesthesia system.

Et Control

by Datex-Ohmeda, Inc., A General Electric Company

PMA P210018

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P210018↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA PMAAPPR Approved	NumberP210018	Date17 Mar 2022Approved	StatusActive

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-0083-2025 FDA Class I initiated 12 Jul 2024
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA PMA Active

Specification

PMA

Generic Name: Software option for anesthesia gas machine to achieve and maintain targeted end tidal oxygen and anesthetic agents

PMA Number: P210018
FDA Product Code: QSF

Device Class: Class III
Advisory Committee: Anesthesiology
FDA Decision: APPR Approved

Overview

AI-generated summary, 18 Sep 2026

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

Et Control is a software option for an anesthesia gas machine designed to achieve and maintain targeted end tidal oxygen and anesthetic agent concentrations. It is indicated for use with the Datex-Ohmeda Aisys CS2 anesthesia system to support clinicians in making multiple, limited adjustments to the fresh gas composition and total flow. The feature is indicated for patients 18 years of age and older and is intended for prescription use only.

The device is supplied as software and is regulated as a Class III medical device. It is intended for use in an anesthetic procedure and is not a standalone device. The software option is part of the Aisys CS2 anesthesia system and operates to support the clinician's settings.

Questions

AI-generated answers, 18 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 primary function of the Et Control software option?

The primary function of the Et Control software option is to support clinicians in maintaining the targeted end tidal oxygen and end tidal anesthetic agent concentrations that they set during an anesthetic procedure. It does this by making multiple, limited adjustments to the fresh gas composition and total flow.
Which anesthesia system is compatible with the Et Control feature?

The Et Control feature is indicated for use with the Datex-Ohmeda Aisys CS2 anesthesia system. It is a software option that is integrated into this specific system to perform its function.
Is the Et Control feature intended for all patients undergoing anesthesia?

No, the Et Control feature is indicated for patients 18 years of age and older. It is intended for prescription use only and is part of the Aisys CS2 anesthesia system.