Cleared Traditional

PHYSIOLOGICAL MONITOR, PATIENT MONITOR

K113441 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular
Mar 2012
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K113441 is an FDA 510(k) clearance for the PHYSIOLOGICAL MONITOR, 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 22, 2012, 122 days after receiving the submission on November 21, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K113441 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2011
Decision Date March 22, 2012
Days to Decision 122 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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