Cleared Traditional

INTELLIVUE PATIENT MONITOR

K093268 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular
May 2010
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K093268 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 May 11, 2010, 204 days after receiving the submission on October 19, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K093268 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2009
Decision Date May 11, 2010
Days to Decision 204 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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