DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE - E-Caiov

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051092

Identifiers

510(k) Number: K051092 FDA 510(k)
FDA Product Code: CCL FDA 510(k)
Models / Variants: Family E-Caiovx) E-Caiovx FDA 510(k)
E-Caiov FDA 510(k)
E-Caio FDA 510(k)
E-Covx FDA 510(k)
E-Cov FDA 510(k)
E-Co FDA 510(k)
Accesacc FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 868.1720 FDA 510(k)
Regulation Number: 868.1720 FDA 510(k)
Advisory Committee: Anesthesiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Datex-Ohmeda S/5 Compact Airway Module is a plug-in module for Datex-Ohmeda S/5 patient monitors, utilizing an AOVA infrared sensor for CO2, N2O, and anesthetic agents, and a paramagnetic sensor for O2. It is used for monitoring respiratory, ventilatory and gas exchange parameters of hospitalized patients.

The device is supplied as a compact module and is intended for use with Datex-Ohmeda S/5 patient monitors. It is regulated under FDA 510K and has a product code of CCL, with a regulation number of 868.1720. The device is available in various models, including E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, and E-CO.

Frequently asked questions

What is the Datex-Ohmeda S/5 Compact Airway Module used for?

The Datex-Ohmeda S/5 Compact Airway Module is used for monitoring respiratory, ventilatory, and gas exchange parameters of hospitalized patients.

How is the device supplied?

The device is supplied as a compact module and is intended for use with Datex-Ohmeda S/5 patient monitors.

What types of sensors does the device utilize?

The device utilizes an AOVA infrared sensor for CO2, N2O, and anesthetic agents, and a paramagnetic sensor for O2.

What are the available models of the device?

The device is available in various models, including E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, and E-CO.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Datex-ohmeda S/5 Compact Airway Module (Model Family E-caiovx) E-caiovx ..., PDF Premarket Notification 510(k) Summary Datex-Ohmeda S/5TM Compact Airway ..., GE Datex-Ohmeda S/5 Series Technical Reference Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K051092	Class II	Active

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Manufacturer

Manufacturer: GE Healthcare

Sources (1)

FDA 510(k) K051092 24 fields · synced Oct 6, 2026