Datex AS/3 Patient Monitor

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

510(k) Number

K933156 ↗

FDA Product Code

DPS

Device Class

Class II

Regulation

21 CFR Part 870.2340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Datex Division Instrumentarium Corp. →

• What types of clinical parameters does the Datex AS/3 Patient Monitor measure in real-time, and how might this benefit acute care settings?

  The Datex AS/3 Patient Monitor measures hemodynamic parameters (such as arrhythmias and ST-segment analysis), respiratory and ventilatory status, and neurophysiological indicators. These capabilities enable continuous clinical assessment of patients in acute care, helping clinicians monitor critical vital signs and detect early signs of instability or complications, such as cardiac arrhythmias or respiratory distress.

• Is the Datex AS/3 Patient Monitor designed for single-use or reusable applications, and what considerations should be taken into account?

  The device is intended for either single-use or reusable applications in acute care, though specific sterility or reuse instructions are not detailed in the regulatory data. If reused, facilities must follow manufacturer guidelines (found in the operator manuals) for cleaning, disinfection, and maintenance to ensure safety and reliability. Proper calibration is also required as part of routine upkeep.

• How is the Datex AS/3 Patient Monitor supplied, and does it require any additional components to function?

  The Datex AS/3 Patient Monitor is supplied as a standalone unit, meaning no external hardware is required for basic operation. However, its functionality depends on proper setup, including sensor attachments (e.g., ECG leads, pulse oximetry probes) and adherence to the operator manual’s calibration and maintenance procedures to ensure accurate monitoring.

• What advisory committee reviewed this device, and what does that imply about its intended clinical focus?

  The device was reviewed by the Cardiovascular (CV) Advisory Committee, which suggests its primary clinical focus aligns with cardiovascular monitoring and assessment. This committee evaluates devices related to heart function, arrhythmias, and hemodynamic stability, reinforcing that the AS/3’s key value lies in its ability to monitor critical cardiac parameters in acute care environments.

• Are there any known storage or shelf-life requirements for the Datex AS/3 Patient Monitor, or should those be determined by the manufacturer?

  The regulatory data does not specify storage conditions or shelf-life requirements for the Datex AS/3 Patient Monitor. Facilities should refer to the manufacturer’s instructions (found in the operator manual) for proper storage, handling, and expiration guidelines to ensure optimal performance and patient safety.