Cleared Traditional

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

K231671 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular
Dec 2023
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K231671 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468), a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medizin Systeme Boeblingen GmbH (B?blingen, DE). The FDA issued a Cleared decision on December 19, 2023, 194 days after receiving the submission on June 8, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K231671 FDA.gov
FDA Decision Cleared SESE
Date Received June 08, 2023
Decision Date December 19, 2023
Days to Decision 194 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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