AS/3 Cardiac Output & SVO2 Module

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K961063 ↗

FDA Product Code

DQK

Device Class

Class II

Regulation

21 CFR Part 870.1425

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Cardiocap II(Tm)

  Class II

  FDA 510(k) K912530 Active Cleared 5 Sep 1991

• As/3 Network Link

  Class II

  FDA 510(k) K953006 Active Cleared 27 Sep 1995

• As/3 Compact Airway Module M-Caiov

  Class II

  FDA 510(k) K960490 Active Cleared 3 May 1996

• As/3 Nmt Module

  Class II

  FDA 510(k) K955026 Active Cleared 28 Apr 1997

• What is the AS/3 Cardiac Output & SVO2 Module used for?

  The AS/3 Cardiac Output & SVO2 Module provides cardiac output (C.O.), right ventricular ejection fraction (REF), and mixed venous oxygen saturation (SvO2) measurements. It is designed for use in Datex AS/3 Anaesthesia Monitor or AS/3 Compact Monitor in anesthesia departments, intensive care departments, and other clinical settings.

• What regulatory approvals does the AS/3 Cardiac Output & SVO2 Module have?

  The module has received FDA 510(k) clearance with number K961063. It is classified as a Class II device and is intended for cardiovascular applications. The clearance was granted on May 31, 1996, after being received on March 18, 1996.

• How is the AS/3 Cardiac Output & SVO2 Module supplied?

  The module is manufactured by Datex Medical Instrumentation, Inc. and is designed to be integrated with Datex AS/3 Anaesthesia Monitor or AS/3 Compact Monitor. It is not supplied as a standalone device but as a module that enhances the monitoring capabilities of these systems.

• In which clinical settings can the AS/3 Cardiac Output & SVO2 Module be used?

  The module is intended for use in anesthesia departments, intensive care departments, and other clinical settings where cardiovascular monitoring is required. It provides invasive measurement of patient parameters that are essential for patient monitoring in these environments.