FDA 510(k)

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

K-Number: K082633 · 2008-10-03

ApplicantPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN

Decision Date2008-10-03

Product CodeDSI

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. It received FDA 510(k) clearance on 2008-10-03 under 510(k) number K082633. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 is a medical device that received FDA 510(k) clearance on 2008-10-03. The listed applicant is Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The 510(k) number is K082633.

When did INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 receive FDA 510(k) clearance?

INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 received FDA 510(k) clearance on 2008-10-03, under 510(k) number K082633.

Who is the listed applicant for INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90?

The FDA 510(k) record lists Philips Medizinsysteme Boeblingen GmbH, Cardiac AN as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90?

The FDA product code for INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 is DSI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Philips Medizinsysteme Boeblingen GmbH, Cardiac AN as applicant

K131872INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550 K131829INTELLIVUE PATIENT MONITOR K130849INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 K120366INTELLIVUE PATIENT MONITOR K113441PHYSIOLOGICAL MONITOR, PATIENT MONITOR K111905INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216

View all 23 devices →

Related Devices (Code: DSI)

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SA K193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.