The following data is part of a premarket notification filed by Philips Medizinsysteme Boblingen Gmbh with the FDA for The Philips Intellivue Mp40, Mp50, Mp60, Mp70,and Mp90 Patient Monitors, Release B.o..
Device ID | K032858 |
510k Number | K032858 |
Device Name: | THE PHILIPS INTELLIVUE MP40, MP50, MP60, MP70,AND MP90 PATIENT MONITORS, RELEASE B.O. |
Classification | Detector And Alarm, Arrhythmia |
Applicant | PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boeblingen, DE D 71034 |
Contact | Hauke Schik |
Correspondent | Hauke Schik PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boeblingen, DE D 71034 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-12 |
Decision Date | 2003-10-10 |
Summary: | summary |