The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Patient Monitors ,models Mp40, Mp50, Mp60, Mp70, Mp80, Mp90.
Device ID | K091927 |
510k Number | K091927 |
Device Name: | INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 |
Classification | Detector And Alarm, Arrhythmia |
Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Contact | Andreas Suchi |
Correspondent | Andreas Suchi PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Product Code | DSI |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-30 |
Decision Date | 2009-11-03 |
Summary: | summary |