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Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories

FDA 510(k)

Class II (US FDA 510(k))

510(k) K023459

by Datex-Ohmeda Inc.

Identifiers

510(k) Number
K023459 FDA 510(k)
FDA Product Code
OLW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1400 FDA 510(k)
Regulation Number
882.1400 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Datex-Ohmeda S/5 Entropy Module, M-Entropy and Accessories is an index-generating electroencephalograph software device. It is designed for use with modular multiparameter monitors to assess the neurophysiological status of hospitalized patients.

This device provides State Entropy, Response Entropy, BSR, and EEG monitoring capabilities for compatible anesthesia monitors. It has received FDA 510(k) clearance and is classified as a Class 2 medical device under regulation number 882.1400.

Frequently asked questions

What is the primary function of the Datex-Ohmeda S/5 Entropy Module?

This device is an index-generating electroencephalograph software module designed to assess the neurophysiological status of hospitalized patients. It provides State Entropy, Response Entropy, BSR, and EEG monitoring capabilities when integrated with compatible modular multiparameter anesthesia monitors.

What is the regulatory classification of this device?

The Datex-Ohmeda S/5 Entropy Module is classified as a Class 2 medical device under regulation number 882.1400. It has received FDA 510(k) clearance, which indicates that the device has been found to be substantially equivalent to legally marketed predicate devices.

How is this module utilized in a clinical setting?

The module is designed for use with modular multiparameter monitors. By processing EEG signals, it assists clinicians in monitoring the patient's neurophysiological state during anesthesia, providing specific indices such as State Entropy and Response Entropy to support clinical decision-making.

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 Entropy Module, M-entropy and Accessories, Datex-ohmeda S/5 Entropy Module, M-entropy and Accessories (K023459 ..., GE Datex-Ohmeda S/5 M-ENTROPY Module - sakomed.com, Datex-Ohmeda S/5 Compact Anesthesia Monitor Technical ... - ManualsLib

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Datex-Ohmeda Inc.
FDA Applicant
Datex-Ohmeda

Sources (1)

  • FDA 510(k) K023459 24 fields · synced Sep 21, 2026