Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K122381 |
Device Name |
NEXFIN MODEL 2 |
Applicant |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Applicant Contact |
MARGUERITE THOMLINSON |
Correspondent |
EDWARDS LIFESCIENCES, LLC. |
ONE EDWARDS WAY |
IRVINE,
CA
92614
|
|
Correspondent Contact |
MARGUERITE THOMLINSON |
Regulation Number | 870.1130
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/06/2012 |
Decision Date | 04/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|