Device Classification Name |
electrocardiograph
|
510(k) Number |
K052049 |
Device Name |
PHILIPS 12-LEAD ALGORITHM |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Applicant Contact |
SONGHUA ZHANG |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Correspondent Contact |
SONGHUA ZHANG |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 07/29/2005 |
Decision Date | 08/26/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|