EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
FDA 510(k) clearance K140312 · decided 2014-06-13
Clearance details
- K-number
- K140312
- Device name
- EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2014-02-07
- Decision date
- 2014-06-13
- Days to decision
- 126 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 |
|---|---|---|
| ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and Cl recall (Z-1732-2015) | Edwards Lifesciences, LLC | 2015-06-09 |