510(k) K180017

MX40 Release C.01 by Philips Medical Systems — Product Code MHX

K180017 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "MX40 Release C.01". The FDA issued a decision of Substantially Equivalent on July 24, 2018. 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 24, 2018
Date Received
January 2, 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