The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Philips Intellivue Patient Monitor, Models Mp40 & Mp50.
Device ID | K040304 |
510k Number | K040304 |
Device Name: | PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP40 & MP50 |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, Baden-wttbg, DE D 71034 |
Contact | Hauke Schik |
Correspondent | Hauke Schik PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, Baden-wttbg, 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 | 2004-02-09 |
Decision Date | 2004-03-01 |
Summary: | summary |