510(k) K031481

THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 by Philips Medizin Systeme Boblingen GmbH — Product Code MHX

K031481 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Boblingen GmbH for the device "THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20". The FDA issued a decision of Substantially Equivalent on May 29, 2003. The device falls under product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.1025. Philips Medizin Systeme Boblingen GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2003
Date Received
May 12, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type