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Datex-Ohmeda S/5 Network and Central '02

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022507

by Datex-Ohmeda Inc.

Identifiers

510(k) Number
K022507 FDA 510(k)
FDA Product Code
MSX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Datex-Ohmeda S/5 Network and Central '02 is a system that maintains network connections between Datex-Ohmeda bedside monitors and other networked devices in the Datex-Ohmeda monitor network. It transfers information between networked Datex-Ohmeda devices and allows for information transfer between multiple Centrals. Within the Datex-Ohmeda monitor network, it enables networked devices to display, store, print, and otherwise process information received from other devices.

The device is supplied as part of a system that includes networked devices and networking hardware. It is a Class II device with FDA 510(k) clearance (K022507) and is regulated under product code MSX. The device is intended for use in cardiovascular settings and is manufactured by Datex-Ohmeda Inc. in Needham, MA.

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: PDF Datex-Ohmeda S/5 Central, ViewStation and Network, DATEX-OHMEDA S/5 NETWORK AND CENTRAL '02 by DATEX-OHMEDA | FDA 510(k ..., Datex Ohmeda S 5 Central network Technical reference manual

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) K022507 24 fields · synced Oct 1, 2026