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Data Exchange System, Model 24

by Siemens Life Support Systems

510(k) K890921

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK890921 Date8 Jun 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CBK
Device Class
Class II
Regulation
21 CFR Part 868.5895
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Data Exchange System, Model 24 is a medical device classified under the product code CBK and associated with the device class 2 ventilator category. It functions as a data exchange interface within clinical environments, facilitating the transfer of information between medical systems. The device is designed for facility use and is intended to support operational data communication in healthcare settings.

This device was submitted for FDA 510(k) clearance under the traditional review pathway by Siemens Life Support Systems, with the application received on February 24, 1989, and a decision of substantial equivalence issued on June 8, 1989. The review was conducted under the Anesthesiology advisory committee. The device is associated with multiple registration numbers and FEI numbers, indicating its integration into various healthcare facilities. No specific information on sterility, reusability, MRI safety, or storage conditions is provided in the available data.

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