Cleared Special

INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550

K131872 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular
Oct 2013
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K131872 is an FDA 510(k) clearance for the INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on October 17, 2013, 115 days after receiving the submission on June 24, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K131872 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2013
Decision Date October 17, 2013
Days to Decision 115 days
Submission Type Special
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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