Cleared Special

INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5

K082583 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular
Feb 2009
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K082583 is an FDA 510(k) clearance for the INTELLIVUE PATIENT MONITOR, INTELLIBRIDGE MODULE, MODELS MP40, MP50, MP60, MP70, MP80, MP90, EC10, EC5, 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 25, 2009, 170 days after receiving the submission on September 8, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K082583 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2008
Decision Date February 25, 2009
Days to Decision 170 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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