The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Patient Monitor, Models Mp2, Mp5, Mp20, Mp30, Mp40, Mp50, Mo60, Mp7-, Mp80, And Mp90.
| Device ID | K083517 |
| 510k Number | K083517 |
| Device Name: | INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Contact | Andreas Suchi |
| Correspondent | Andreas Suchi PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-26 |
| Decision Date | 2009-01-16 |
| Summary: | summary |