Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K121638 |
Device Name |
ST80I STRESS TEST SYSTEM |
Applicant |
PHILIPS HEALTHCARE |
1525 RANCHO CONEJO BLVD |
SUITE 100 |
THOUSAND OAKS,
CA
91320
|
|
Applicant Contact |
GRETAL LUMLEY |
Correspondent |
PHILIPS HEALTHCARE |
1525 RANCHO CONEJO BLVD |
SUITE 100 |
THOUSAND OAKS,
CA
91320
|
|
Correspondent Contact |
GRETAL LUMLEY |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 06/04/2012 |
Decision Date | 07/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|