The following data is part of a premarket notification filed by Philips Medizinsysteme Boblingen Gmbh with the FDA for Intellivue Patient Monitor, Models Mp2, X2, Mp5, Mp5t, Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80, Mp90, & Mx800.
| Device ID | K102562 |
| 510k Number | K102562 |
| Device Name: | INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH HEWLETT PACKARD STR. 2 Boblingen, DE D 71034 |
| Contact | Andreas Suchi |
| Correspondent | Andreas Suchi PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH HEWLETT PACKARD STR. 2 Boblingen, 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 | 2010-09-07 |
| Decision Date | 2010-10-21 |
| Summary: | summary |