Identifiers
- 510(k) Number
- K110597 FDA 510(k)
- FDA Product Code
- DXG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1435 FDA 510(k)
- Regulation Number
- 870.1435 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EV1000 Clinical Platform is a diagnostic, pre-programmed, single-function computer. It is designed to present the physiologic status of a patient in an intuitive manner.
This device is authorized under FDA 510(k) clearance K110597. It is intended for use in clinical settings as a cardiovascular diagnostic tool.
Frequently asked questions
What is the primary function of the EV1000 Clinical Platform?
The EV1000 Clinical Platform is a diagnostic, pre-programmed, single-function computer. It is designed to present the physiologic status of a patient in an intuitive manner for use in clinical settings.
What is the intended use of this device?
The device is intended for use as a cardiovascular diagnostic tool to assist clinicians in assessing a patient's physiologic status.
Is the EV1000 Clinical Platform authorized for use?
Yes, the device is authorized under FDA 510(k) clearance K110597, which confirms it has been reviewed and found to be substantially equivalent to existing devices.
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: EV1000 clinical platform | Edwards Lifesciences, EDWARDS EV1000 OPERATOR'S MANUAL Pdf Download | ManualsLib, EV1000 Clinical Platform - Edwards Lifesciences - PDF Catalogs ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110597 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences
Sources (1)
- FDA 510(k) K110597 24 fields · synced Sep 26, 2026