Device Classification Name |
Detector And Alarm, Arrhythmia
|
510(k) Number |
K150310 |
Device Name |
IntelliVue Patient Monitor |
Applicant |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
71034
|
|
Applicant Contact |
JOHANNES SCHMID |
Correspondent |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
71034
|
|
Correspondent Contact |
JOHANNES SCHMID |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/09/2015 |
Decision Date | 05/13/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|