Device Classification Name |
electrocardiograph
|
510(k) Number |
K113306 |
Device Name |
CARDIO 7 |
Applicant |
BIONET CO., LTD. |
5405 ALTON PARKWAY, |
SUITE A530 |
IRVINE,
CA
92604
|
|
Applicant Contact |
MARC GOODMAN |
Correspondent |
BIONET CO., LTD. |
5405 ALTON PARKWAY, |
SUITE A530 |
IRVINE,
CA
92604
|
|
Correspondent Contact |
MARC GOODMAN |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 11/09/2011 |
Decision Date | 07/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|