Device Classification Name |
electrocardiograph
|
510(k) Number |
K052898 |
Device Name |
IQMARK EZ STRESS |
Applicant |
BRENTWOOD MEDICAL TECHNOLOGY CORP. |
3300 FUJITA ST. |
TORRANCE,
CA
90505
|
|
Applicant Contact |
RUOMEI ZHANG |
Correspondent |
INTERTEK TESTING SERVICES |
70 CODMAN HILL RD. |
BOXBOROUGH,
MA
01719
|
|
Correspondent Contact |
NEIL E DEVINE |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 10/14/2005 |
Decision Date | 03/28/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|