Cleared Traditional

IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)

K250453 · Philips Medizin Systeme B?blingen GmbH · Cardiovascular
Sep 2025
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K250453 is an FDA 510(k) clearance for the IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500), a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medizin Systeme B?blingen GmbH (Boeblingen, DE). The FDA issued a Cleared decision on September 2, 2025, 196 days after receiving the submission on February 18, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K250453 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2025
Decision Date September 02, 2025
Days to Decision 196 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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