Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K150975 |
Device Name |
Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors |
Applicant |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
Hewlett-Packard Str. 2 |
Boeblingen, Baden Wuerttemberg,
DE
71034
|
|
Applicant Contact |
Michael Asmalsky |
Correspondent |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
Hewlett-Packard Str. 2 |
Boeblingen, Baden Wuerttemberg,
DE
71034
|
|
Correspondent Contact |
Michael Asmalsky |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/13/2015 |
Decision Date | 06/25/2015 |
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
|
|
|