Cleared Special

INTELLIVUE MX40 PATIENT MONITOR

K103646 · Phillips Medical Systems · Cardiovascular
Jan 2011
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K103646 is an FDA 510(k) clearance for the INTELLIVUE MX40 PATIENT MONITOR, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Phillips Medical Systems (Andover, US). The FDA issued a Cleared decision on January 7, 2011, 24 days after receiving the submission on December 14, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K103646 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2010
Decision Date January 07, 2011
Days to Decision 24 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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