Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K160552 |
Device Name |
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform |
Applicant |
EDWARDS LIFESCIENCES, LLC |
ONE EDWARDS WAY |
Irvine,
CA
92614
|
|
Applicant Contact |
Tara Viviani |
Correspondent |
EDWARDS LIFESCIENCES, LLC |
ONE EDWARDS WAY |
Irvine,
CA
92614
|
|
Correspondent Contact |
Tara Viviani |
Regulation Number | 870.1130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/29/2016 |
Decision Date | 06/01/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|