The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Patient Monitor.
Device ID | K120366 |
510k Number | K120366 |
Device Name: | INTELLIVUE PATIENT MONITOR |
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 | BZC |
Subsequent Product Code | BZQ |
Subsequent Product Code | CBQ |
Subsequent Product Code | CBR |
Subsequent Product Code | CBS |
Subsequent Product Code | CCK |
Subsequent Product Code | CCL |
Subsequent Product Code | DPS |
Subsequent Product Code | DQA |
Subsequent Product Code | DRG |
Subsequent Product Code | DRJ |
Subsequent Product Code | DRQ |
Subsequent Product Code | DRS |
Subsequent Product Code | DRT |
Subsequent Product Code | DRW |
Subsequent Product Code | DSA |
Subsequent Product Code | DSB |
Subsequent Product Code | DSF |
Subsequent Product Code | DSH |
Subsequent Product Code | &nb |
CFR Regulation Number | 870.1025 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-02-06 |
Decision Date | 2012-07-18 |
Summary: | summary |