Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216

FDA 510(k) K111905 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

Substantially Equivalent

510(k) numberK111905

Submission

Device name
Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216
Applicant
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
Boeblingen, Baden-Wuerttemberg, DE
Received
July 5, 2011
Decision date
October 4, 2011
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXJ – Display, Cathode-Ray Tube, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2450
Specialty
Cardiovascular

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More from Barco N.V.

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K131872Intellivue Patient Monitor MX500, Intellivue Patient Monitor MX550MHX · Special 10/17/2013SE
K131829Intellivue Patient MonitorMHX · Special 08/16/2013SE
K130849Intellivue Patient Monitor MX400; Intellivue Patient Monitor MX450MHX · Special 06/14/2013SE
K120366Intellivue Patient MonitorMHX · Abbreviated 07/18/2012SE
K113441Physiological Monitor, Patient MonitorMHX · Traditional 03/22/2012SE
K110474Philips Intellivue TCG10LKD · Abbreviated 09/30/2011SE
K111083Philips Avalon Fetal/Maternal Monitors FM20, FM30, FM40 and FM50HGM · Abbreviated 08/17/2011SE
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Questions and answers

When was Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 cleared by the FDA?

Intellivue Guardian Software Model 866009, Intellivue CL SP02 Pod Model 865215, Intellivue CL NBP Pod Model 865216 (K111905) received a 510(k) decision of Substantially Equivalent on October 4, 2011, 91 days after the submission was received.

What is the product code of K111905?

The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.