Cleared Special

INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90

K082633 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular
Oct 2008
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K082633 is an FDA 510(k) clearance for the INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, 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 October 3, 2008, 23 days after receiving the submission on September 10, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K082633 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2008
Decision Date October 03, 2008
Days to Decision 23 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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