Datex-Ohmeda S/5 E-PSM(P) Module (Consisting of E-PSM, E-PSMP and E-INTPSM Modules) and Accessories
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K062576 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1025 FDA 510(k)
- Regulation Number
- 870.1025 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Physiological Monitor, Patient (with Arrhythmia Detection or Alarms) designed for continuous hemodynamic monitoring in hospitalized patients. It integrates multiple modules—including the E-PSM, E-PSMP, and E-INTPSM—to measure and display critical cardiovascular parameters such as blood pressure, heart rate, and arrhythmia events, aiding clinical assessment and intervention.
The Datex-Ohmeda S/5 E-PSM(P) Module is supplied as a reusable system for use in hospital settings, including intensive care units and cardiac care. It operates in non-sterile environments and is classified as a Class II device under FDA regulation 870.1025. The system includes proprietary modules and accessories, with no specific MRI safety labeling indicated. Authorized for use in the United States via FDA 510(k) clearance (K062576), it adheres to cardiovascular monitoring standards for arrhythmia detection and alarm functionality.
Frequently asked questions
What types of clinical environments is the Datex-Ohmeda S/5 E-PSM(P) Module designed for, and what specific monitoring capabilities does it provide?
The Datex-Ohmeda S/5 E-PSM(P) Module is specifically designed for use in hospitalized patient settings, including intensive care units (ICUs) and cardiac care units. It is a physiological monitor with arrhythmia detection and alarm functionality, enabling continuous monitoring of critical cardiovascular parameters such as blood pressure, heart rate, and arrhythmia events. This helps clinicians assess and respond to hemodynamic changes in real time.
Is the Datex-Ohmeda S/5 E-PSM(P) Module intended for single-use or reusable applications, and what are the environmental conditions for its use?
The Datex-Ohmeda S/5 E-PSM(P) Module is not single-use—it is designed as a reusable system for hospital environments. Since it operates in non-sterile settings, it is not intended for sterile procedures or direct patient contact in sterile fields. Proper cleaning and maintenance protocols must be followed per manufacturer guidelines to ensure safe, repeated use.
What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?
The Datex-Ohmeda S/5 E-PSM(P) Module received FDA 510(k) clearance under the Special 510(k) pathway, classified as a Class II device under regulation 21 CFR 870.1025. The submission was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device, adhering to cardiovascular monitoring standards for arrhythmia detection and alarms.
Does this device include any proprietary modules or accessories, and are there any specific MRI safety considerations mentioned?
Yes, the Datex-Ohmeda S/5 E-PSM(P) Module consists of proprietary modules (E-PSM, E-PSMP, and E-INTPSM) along with associated accessories. However, there is no MRI safety labeling indicated for this device, meaning it should not be used in MRI environments or near magnetic fields unless explicitly approved for such use by the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Datex-ohmeda S/5 Psm Module, (Consisting of E-psm and E-psmp Modules ..., DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF… - FDA.report, FDA Browser - Cleared 510 (K) - DATEX-OHMEDA S/5 E-PSM (P) MODULE ..., DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K062576 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K062576 24 fields · synced Sep 18, 2026