510(k) K221348

IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) by Philips Medizin Systeme Böblingen GmbH — Product Code MHX

K221348 is an FDA 510(k) premarket notification submitted by Philips Medizin Systeme Böblingen GmbH for the device "IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470)". The FDA issued a decision of Substantially Equivalent on February 3, 2023. 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
February 3, 2023
Date Received
May 9, 2022
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