PM-8000 Patient Monitor Modification
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K043348 FDA 510(k)
- FDA Product Code
- MWI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2300 FDA 510(k)
- Regulation Number
- 870.2300 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PM-8000 Patient Monitor Modification is a cardiovascular patient monitoring device designed to continuously assess and display vital signs such as ECG, blood pressure, pulse oximetry, and respiratory parameters. It is intended for use in clinical settings to provide real-time physiological monitoring of patients, supporting diagnostic and therapeutic decision-making.
This modification is supplied as a reusable device, intended for use in hospital or critical care environments. It is regulated under FDA 510(k) clearance (K043348) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device is classified under product code MWI and is intended for specialized cardiovascular monitoring applications.
Frequently asked questions
What types of vital signs does the PM-8000 Patient Monitor Modification continuously monitor and display in real-time?
The PM-8000 Patient Monitor Modification continuously assesses and displays ECG (electrocardiogram), blood pressure, pulse oximetry (SpO₂), and respiratory parameters. These measurements support real-time physiological monitoring for patients in clinical or critical care settings, helping clinicians make informed diagnostic and therapeutic decisions.
Is the PM-8000 Patient Monitor Modification intended for single-use or reusable applications in a hospital environment?
The PM-8000 Patient Monitor Modification is designed as a reusable device, specifically intended for use in hospital or critical care environments where durability and repeated use are required. This makes it suitable for long-term monitoring in settings like ICUs or operating rooms.
What regulatory pathways does the PM-8000 Patient Monitor Modification follow, and how does it classify under FDA and EU standards?
The PM-8000 Patient Monitor Modification is cleared under the FDA 510(k) pathway with clearance number K043348, classified as substantially equivalent (SESE) and reviewed by the Cardiovascular (CV) Advisory Committee. It complies with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR) in the EU, falling under product code MWI for specialized cardiovascular monitoring applications.
What clinical settings is this device primarily intended for, and what kind of patients would benefit from its monitoring capabilities?
The PM-8000 Patient Monitor Modification is designed for clinical and critical care environments, such as hospitals, ICUs, or operating rooms. It is particularly useful for patients requiring continuous cardiovascular monitoring, including those with complex or unstable conditions where real-time tracking of ECG, blood pressure, oxygen saturation, and respiration is critical for decision-making.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K043348 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K043348 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 2, 2026