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 | K101449 |
| 510k Number | K101449 |
| 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 71034 |
| Contact | Andreas Suchi |
| Correspondent | Andreas Suchi PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE 71034 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-24 |
| Decision Date | 2010-06-18 |
| Summary: | summary |