Cleared Special

INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90

K083517 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular
Jan 2009
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K083517 is an FDA 510(k) clearance for the INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN (Boeblingen, Baden-Wuerttemberg, DE). The FDA issued a Cleared decision on January 16, 2009, 51 days after receiving the submission on November 26, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K083517 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2008
Decision Date January 16, 2009
Days to Decision 51 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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