EW200 System (Oxygen Saturation Monitoring System) and Presep Oximetry Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060660 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 EW200 System is a computer-based diagnostic device used for monitoring hemodynamic parameters, including oxygen saturation and hemoglobin levels. It is intended for use in patients requiring continuous monitoring of these vital signs.
The Presep Oximetry Catheter is used with the EW200 System to measure oxygen saturation and hemoglobin levels. The device is supplied as a single-use component and is not reusable. The system is not MRI safe.
Frequently asked questions
What is the EW200 System used for?
The EW200 System is a computer-based diagnostic device used to monitor hemodynamic parameters, specifically oxygen saturation and hemoglobin levels, in patients requiring continuous vital sign monitoring.
Is the Presep Oximetry Catheter reusable?
No, the Presep Oximetry Catheter is supplied as a single-use component and is not intended for reuse.
Is this device compatible with MRI environments?
No, the EW200 System is not MRI safe and should not be used in an MRI environment.
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: Ew200 System (Oxygen Saturation Monitoring System) and Presep Oximetry ..., PDF K060660 Ew200 System (Oxygen Saturation Monitoring System) and Presep ..., PDF APR 2 52006 - Food and Drug Administration, PreSep Catheter - Edwards Lifesciences - PDF Catalogs | Technical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060660 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K060660 24 fields · synced Oct 1, 2026