The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for The Philips Intellivue Patient Monitors, Models Mp20,mp30,mp40,mp50,mp60,mp70,mp80,mp90.
| Device ID | K061052 |
| 510k Number | K061052 |
| Device Name: | THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. HEWLETT-PACKARD-STR. 2 Boeblingen, DE D-71034 |
| Contact | Hauke Schik |
| Correspondent | Hauke Schik PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. HEWLETT-PACKARD-STR. 2 Boeblingen, 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 | 2006-04-17 |
| Decision Date | 2006-05-26 |
| Summary: | summary |