Device Classification Name |
Computer, Diagnostic, Programmable
|
510(k) Number |
K191089 |
Device Name |
Edwards Pressure Cable |
Applicant |
Edwards LifeSciences, LLC |
One Edwards Way |
Irvine,
CA
92614
|
|
Applicant Contact |
Anne Lo |
Correspondent |
Edwards LifeSciences, LLC |
One Edwards Way |
Irvine,
CA
92614
|
|
Correspondent Contact |
Anne Lo |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 04/24/2019 |
Decision Date | 06/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|