Device Classification Name |
electrocardiograph
|
510(k) Number |
K080999 |
Device Name |
PAGEWRITER CARDIOGRAPH |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Applicant Contact |
PAUL SCHRADER |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Correspondent Contact |
PAUL SCHRADER |
Regulation Number | 870.2340
|
Classification Product Code |
|
Date Received | 04/08/2008 |
Decision Date | 05/09/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|