Cleared Special

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

K062283 · Philips Medical Systems North America, Inc. · Cardiovascular
Sep 2006
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K062283 is an FDA 510(k) clearance for the THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 INTELLIVUE PATIENT MONITORS, 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 September 20, 2006, 44 days after receiving the submission on August 7, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K062283 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2006
Decision Date September 20, 2006
Days to Decision 44 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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