The following data is part of a premarket notification filed by Philips Medizinsysteme Boblingen Gmbh with the FDA for The Philips Intellivue Mp60, Mp70, And Mp90 Patient Monitors, Release A.20.
| Device ID | K031481 |
| 510k Number | K031481 |
| Device Name: | THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH HEWLETT-PACKARD STR.2 Boblingen, DE D 71034 |
| Contact | Hauke Schik |
| Correspondent | Hauke Schik 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 | 2003-05-12 |
| Decision Date | 2003-05-29 |
| Summary: | summary |