Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K120855 |
Device Name |
INTELLISPACE ECG |
Applicant |
PHILIPS HEALTHCARE |
1525 RANCHO CONEJO BLVD |
SUITE 100 |
THOUSAND OAKS,
CA
91320
|
|
Applicant Contact |
GRETEL LUMLEY |
Correspondent |
PHILIPS HEALTHCARE |
1525 RANCHO CONEJO BLVD |
SUITE 100 |
THOUSAND OAKS,
CA
91320
|
|
Correspondent Contact |
GRETEL LUMLEY |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 03/21/2012 |
Decision Date | 06/29/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|