Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K093177 |
Device Name |
INTELLIBRIDGE SYSTEM |
Applicant |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Applicant Contact |
CLAIRE ARAKAKI |
Correspondent |
PHILIPS MEDICAL SYSTEMS |
3000 MINUTEMAN RD. |
ANDOVER,
MA
01810 -1099
|
|
Correspondent Contact |
CLAIRE ARAKAKI |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 10/08/2009 |
Decision Date | 12/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|