CS/3(TM) MONITORS*

• K Number: K974792
• Device Name: CS/3(TM) MONITORS*
• Manufacturer: DATEX-ENGSTROM, INC.
• Date Cleared: 1998-06-02 ( 162 days)
• Product Code: DSI
• Regulation Number: 870.1025
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The CS/3™ Monitors are indicated for multiparameter patient monitoring in all hospital patients.

Device Description

CS/3™ Monitors* * Includes CS/3™ Critical Care Monitor and CS/3™ Compact Monitor.

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Datex Engstrom, Inc. CS/3™ Monitors. It indicates the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, study details, performance metrics, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The document primarily focuses on regulatory approval and indications for use.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.