The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for The Philips Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80, Mp90 Intellivue Patient Monitors.
Device ID | K062283 |
510k Number | K062283 |
Device Name: | THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS |
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 | Andreas Suchi |
Correspondent | Andreas Suchi 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 | 2006-08-07 |
Decision Date | 2006-09-20 |
Summary: | summary |