Cleared Traditional

IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )

K251702 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular
Nov 2025
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K251702 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 ), a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medizin Systeme B?blingen GmbH (B?blingen, DE). The FDA issued a Cleared decision on November 10, 2025, 161 days after receiving the submission on June 2, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K251702 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2025
Decision Date November 10, 2025
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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