The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Philips Model Mp20, Mp30, Mp40, Mp50, Mp60, Mp70, Mp80 And Mp90 Intellivue Patient Monitors.
Device ID | K061610 |
510k Number | K061610 |
Device Name: | PHILIPS MODEL MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS |
Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, DE D-71034 |
Contact | Hauke Schik |
Correspondent | Hauke Schik PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH 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 | 2006-06-09 |
Decision Date | 2006-08-14 |
Summary: | summary |