Spacelabs Medical Expansion Module (Model 90352)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K945429 ↗

FDA Product Code

DSI

Device Class

Class II

Regulation

21 CFR Part 870.1025

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Spacelabs Medical, Inc. →

• What is the Spacelabs Medical Expansion Module Model 90352 used for?

  The Spacelabs Medical Expansion Module (Model 90352) is a cardiovascular device designed as a detector and alarm for arrhythmia. It expands the functionality of medical monitoring systems in healthcare settings, particularly in hospitals and healthcare facilities.

• How is the Spacelabs Medical Expansion Module supplied?

  The device is supplied as a single unit and is intended for use in hospitals and healthcare facilities. It is designed to integrate with existing medical monitoring systems to enhance their capabilities.

• What is the regulatory classification of the Spacelabs Medical Expansion Module?

  The Spacelabs Medical Expansion Module has received FDA 510(k) clearance with product code DSI and is classified as a Class II medical device under regulation 870.1025. It was determined to be substantially equivalent to other devices on the market.

• Is the Spacelabs Medical Expansion Module reusable or single-use?

  The device data does not specify whether the Spacelabs Medical Expansion Module is designed for single-use or reuse. For information on reusability, users should consult the product documentation or contact the manufacturer directly.