510(k) K193179
K193179 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "EV1000 Clinical Platform". The FDA issued a decision of Substantially Equivalent on December 17, 2019. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Edwards Lifesciences, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2019
- Date Received
- November 18, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Diagnostic, Pre-Programmed, Single-Function
- Device Class
- Class II
- Regulation Number
- 870.1435
- Review Panel
- CV
- Submission Type