EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
FDA 510(k) clearance K160552 · decided 2016-06-01
Clearance details
- K-number
- K160552
- Device name
- EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-02-29
- Decision date
- 2016-06-01
- Days to decision
- 93 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monit recall (Z-1193-2019) | Edwards Lifesciences, LLC | 2019-05-21 |