The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Patient Monitor Mx400, Intellivue Patient Monitor Mx450, Intellivue Patient Monitor Mx500, Intellivue Patient.
Device ID | K141015 |
510k Number | K141015 |
Device Name: | INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Contact | Markus Stacha |
Correspondent | Markus Stacha PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
Product Code | MHX |
Subsequent Product Code | DSJ |
Subsequent Product Code | DSK |
Subsequent Product Code | GWS |
Subsequent Product Code | MLD |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-04-21 |
Decision Date | 2014-05-19 |
Summary: | summary |