DATEX-OHMEDA PRESTIN MODULE - E-P
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K051217 FDA 510(k)
- FDA Product Code
- MHX FDA 510(k)
- Models / Variants
- model Family E-Prestin FDA 510(k)Including E-Prestin FDA 510(k)E-Restin FDA 510(k)E=pretin FDA 510(k)E-Pp And E-Pt FDA 510(k)E-P 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)
The Datex-Ohmeda Prestin Module is a physiological monitor with arrhythmia detection or alarms, used for monitoring hemodynamic parameters. It supports various parameters such as ECG, impedance respiration, NIBP, SpO₂, temperature, and invasive pressure channels. The device is designed to be used with modular monitors for anesthesia, ICU, and perioperative monitoring workflows.
The Datex-Ohmeda Prestin Module is supplied as a double-width multiparameter hemodynamic module for compatible GE and Datex-Ohmeda modular monitors. It has been authorized with an FDA 510K clearance. The device is part of the medical specialty of cardiovascular monitoring, with a regulation number of 870.1025 and a product code of MHX.
Frequently asked questions
What parameters can the Datex-Ohmeda Prestin Module monitor?
The device supports various parameters such as ECG, impedance respiration, NIBP, SpO₂, temperature, and invasive pressure channels.
Is the Datex-Ohmeda Prestin Module supplied sterile?
The description does not specify if the device is supplied sterile, but it is designed for use in medical settings where sterility is crucial.
Can the Datex-Ohmeda Prestin Module be used with other monitors?
The device is designed to be used with modular monitors for anesthesia, ICU, and perioperative monitoring workflows, specifically compatible GE and Datex-Ohmeda modular monitors.
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 Prestin Module (Model Family E-prestin, Including E ..., GE Datex-Ohmeda E-PRESTN Module - SakoMed Biomedical Services, Datex-ohmeda Prestin Module (model Family E-prestin, Including E ..., GE Healthcare Datex Ohmeda GE E-PRESTN-00 Module Patient Monitor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051217 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K051217 24 fields · synced Oct 6, 2026