510(k) K182979

IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 by Philips Medizin Systeme Boeblingen GmbH — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2019
Date Received
October 26, 2018
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