Cleared Abbreviated

INTELLIVUE PATIENT MONITOR

K120366 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular
Jul 2012
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K120366 is an FDA 510(k) clearance for the INTELLIVUE PATIENT MONITOR, 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 July 18, 2012, 163 days after receiving the submission on February 6, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K120366 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2012
Decision Date July 18, 2012
Days to Decision 163 days
Submission Type Abbreviated
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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