510(k) K211900

Patient Information Center iX by Philips Medizin Systeme Böblingen GmbH — Product Code MHX

K211900 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Böblingen GmbH for the device "Patient Information Center iX". The FDA issued a decision of Substantially Equivalent on March 4, 2022. 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 Böblingen GmbH has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2022
Date Received
June 21, 2021
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