510(k) K163584

M3290B Philips IntelliVue Information Center iX by Philips Medical Systems — Product Code MHX

K163584 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "M3290B Philips IntelliVue Information Center iX". The FDA issued a decision of Substantially Equivalent on July 7, 2017. 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 Medical Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2017
Date Received
December 20, 2016
Clearance Type
Traditional
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