MDP2000 Medical Data Processor
FDA 510(k)Class II (US FDA 510(k))
by Vidco, Inc
Identifiers
- 510(k) Number
- K972880 FDA 510(k)
- FDA Product Code
- MSX 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 MDP2000 Medical Data Processor is a System, Network and Communication Device designed for physiological monitoring. It functions as a data acquisition and processing unit, interfacing with patient monitoring equipment to receive analog or digital physiological signals for analysis, storage, and transmission without direct patient connection.
This device is intended for use in clinical settings, such as hospitals or cardiac care units, where real-time or archived physiological data must be managed. Supplied as a reusable Class II medical device, it adheres to FDA 510(k) clearance (K972880) under regulation 870.2300. No specific sterility or MRI safety information is provided in the data, and its operational specifications are governed by regulatory compliance with the stated authorization.
Frequently asked questions
What clinical environments is the MDP2000 Medical Data Processor designed for, and how does it integrate with existing systems?
The MDP2000 is intended for use in clinical settings like hospitals and cardiac care units where real-time or archived physiological data management is required. It functions as a data acquisition and processing unit, interfacing with patient monitoring equipment to receive analog or digital physiological signals for analysis, storage, and transmission—without direct patient contact. This makes it suitable for environments where centralized monitoring and data aggregation are critical, such as intensive care units or cardiac catheterization labs.
Is the MDP2000 a single-use or reusable device, and what does this mean for maintenance and cleaning?
The MDP2000 is classified as a reusable Class II medical device. This means it is designed for repeated use in clinical settings, requiring proper cleaning, disinfection, and maintenance between uses to ensure reliability and safety. Since it does not require sterility (as no sterility claims are made), its reuse is governed by facility-specific protocols for medical device reprocessing.
What regulatory pathway was followed for FDA clearance of the MDP2000, and what does this imply about its safety and performance?
The MDP2000 received FDA clearance through a 510(k) submission (K972880) under the Traditional 510(k) Review pathway, with a Substantially Equivalent determination by the Cardiovascular (CV) Advisory Committee. This implies that the device was compared to a legally marketed predicate and deemed to have the same intended use, indications, and safety risks. The clearance was granted under FDA regulation 870.2300, which covers System, Network and Communication Devices for physiological monitoring.
Does the MDP2000 require any special storage conditions, and how should it be handled to ensure optimal performance?
The provided data does not specify any special storage conditions (e.g., temperature, humidity, or environmental protection) for the MDP2000. However, as a reusable medical device, it should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of electromagnetic interference to prevent damage to its electronic components. Always follow manufacturer guidelines for setup, calibration, and maintenance to ensure reliable operation.
What types of physiological signals can the MDP2000 process, and how does it transmit data for clinical use?
The MDP2000 is designed to receive analog or digital physiological signals from patient monitoring equipment, such as ECG, blood pressure, or other vital signs. It processes these signals for analysis, storage, and transmission—typically to a network or centralized monitoring system—without direct patient contact. This allows clinicians to review real-time or archived data for diagnostic or treatment purposes, though the exact signal types supported would depend on compatible monitoring devices used in conjunction with it.
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: K972880 FDA 510 (k) - MDP2000 MEDICAL DATA PROCESSOR, MDP2000 MEDICAL DATA PROCESSOR (K972880) — FDA 510(k) | Innolitics, MDP2000 MEDICAL DATA PROCESSOR 510 (k) K972880 - FDA.report, MDP2000 MEDICAL DATA… — K972880 · DeviceClearance, Vidco, Inc. FDA 510 (k) Products (1989-1997)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K972880 | Class II | Active |
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Manufacturer
- Manufacturer
- Vidco, Inc
- FDA Applicant
- Vidco, Inc.
Sources (1)
- FDA 510(k) K972880 24 fields · synced Sep 19, 2026