Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K060541 |
Device Name |
THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS |
Applicant |
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
HEWLETT PACKARD STR. 2 |
BOBLINGEN,
DE
D 71034
|
|
Applicant Contact |
HERBERT VAN DYK |
Correspondent |
PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
HEWLETT PACKARD STR. 2 |
BOBLINGEN,
DE
D 71034
|
|
Correspondent Contact |
HERBERT VAN DYK |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/01/2006 |
Decision Date | 03/24/2006 |
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
|
|
|