Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor, MODEL-2
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K023338 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor, Model-2 is a device that provides continuous, noninvasive blood pressure and pulse rate monitoring. It enables 24-hour continuous ambulatory measurements, and when used with the PC-based BeatScope software, it provides Modelflow-based computation of real-time and beat-to-beat blood pressure as well as hemodynamic parameters from the pressure waveform. The device is used for monitoring blood pressure and hemodynamic parameters, including cardiac output and total peripheral resistance.
The Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor, Model-2 is supplied with the BeatScope software and is intended to provide the user with continuous, noninvasive blood pressure and pulse rate monitoring. The device has received FDA 510K authorization and is classified under product code DXN. It is available from Finapres Medical Systems BV, and the manufacturer provides solutions for continuous non-invasive blood pressure and hemodynamic monitoring.
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: Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor,Model-2, Portapres Ambulatory Continuous Non Invasive Blood Pressure Monitor ..., Homepage | Finapres Medical Systems, PDF Portapres Model-2 - Frank's Hospital Workshop
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023338 | Class II | Active |
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Manufacturer
- Manufacturer
- Fms, Finapres Medical Systems BV
Sources (1)
- FDA 510(k) K023338 24 fields · synced Sep 24, 2026