Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K110622 |
Device Name |
INTELLIVUE PATIENT MONITOR |
Applicant |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
D 71034
|
|
Applicant Contact |
HERBERT VAN DYK |
Correspondent |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
HEWLETT-PACKARD STR.2 |
BOEBLINGEN,
DE
D 71034
|
|
Correspondent Contact |
HERBERT VAN DYK |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 03/03/2011 |
Decision Date | 03/31/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|