Cleared Special

INTELLIVUE PATIENT MONITOR

K110622 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular
Mar 2011
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K110622 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 March 31, 2011, 28 days after receiving the submission on March 3, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K110622 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2011
Decision Date March 31, 2011
Days to Decision 28 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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