The following data is part of a premarket notification filed by Philips Medizin Systeme Boblingen Gmbh with the FDA for Philips Intellivue Mp5 Patient Monitor.
Device ID | K083228 |
510k Number | K083228 |
Device Name: | PHILIPS INTELLIVUE MP5 PATIENT MONITOR |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE D-71034 |
Contact | Jens-peter Seher |
Correspondent | Jens-peter Seher PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE D-71034 |
Product Code | MHX |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-11-03 |
Decision Date | 2008-11-24 |
Summary: | summary |