Cleared Traditional

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

K230604 · Philips Medizin Systeme Boeblingen GmbH · Cardiovascular
Nov 2023
Decision
264d
Days
Class 2
Risk

About This 510(k) Submission

K230604 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030), 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 November 22, 2023, 264 days after receiving the submission on March 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K230604 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2023
Decision Date November 22, 2023
Days to Decision 264 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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