510(k) K203131
K203131 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform". The FDA issued a decision of Substantially Equivalent on Jan 22, 2021. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Edwards Lifesciences, LLC has 157 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 22, 2021
- Date Received
- Oct 19, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type
- 510(k)