IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066)

About This 510(k) Submission

K223574 is an FDA 510(k) clearance for the IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066), 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 August 22, 2023, 265 days after receiving the submission on November 30, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.