Cleared Special

K091395 - MP5 INTELLIVUE PATIENT MONITOR
(FDA 510(k) Clearance)

K091395 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Cardiovascular

Jun 2009

Decision

25d

Days

Class 2

Risk

K091395 is an FDA 510(k) clearance for the MP5 INTELLIVUE 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 June 5, 2009, 25 days after receiving the submission on May 11, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K091395 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2009
Decision Date	June 05, 2009
Days to Decision	25 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