510(k) K151812

PATIENT MONITORS VARIOUS MODELS by Philips Medical Systems — Product Code MHX

K151812 is an FDA 510(k) premarket notification submitted by Philips Medical Systems for the device "PATIENT MONITORS VARIOUS MODELS". The FDA issued a decision of Substantially Equivalent on January 26, 2016. 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
January 26, 2016
Date Received
July 2, 2015
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