Cleared Special

THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90

K061052 · Philips Medical Systems North America, Inc. · Cardiovascular
May 2006
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K061052 is an FDA 510(k) clearance for the THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Philips Medical Systems North America, Inc. (Boeblingen, DE). The FDA issued a Cleared decision on May 26, 2006, 39 days after receiving the submission on April 17, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K061052 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2006
Decision Date May 26, 2006
Days to Decision 39 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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