PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH

The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh with the FDA for Philips Mp40, Mp50, Mp60, Mp70, Mp80 And Mp90 Intellivue Patient Monitors, Release D.00.

Pre-market Notification Details

• Device ID: K053522
• 510k Number: K053522
• Device Name: PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, Baden-wttbg, DE D-71034
• Contact: Herbert Van Dyk
• Correspondent: Herbert Van Dyk; PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH HEWLETT-PACKARD STR.2 Boeblingen, Baden-wttbg, 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: 2005-12-19
• Decision Date: 2006-01-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20884838072200	K053522	000