Cleared Traditional

MP5 INTELLIVUE PATIENT MONITOR

K063725 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular
Feb 2007
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K063725 is an FDA 510(k) clearance for the MP5 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 February 8, 2007, 55 days after receiving the submission on December 15, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K063725 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2006
Decision Date February 08, 2007
Days to Decision 55 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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