FDA 510(k)

INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90

K-Number: K100939 · 2010-04-30

ApplicantPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN

Decision Date2010-04-30

Product CodeMHX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND 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 2010-04-30 under 510(k) number K100939. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90?

INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 is a medical device that received FDA 510(k) clearance on 2010-04-30. The listed applicant is Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. The 510(k) number is K100939.

When did INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 receive FDA 510(k) clearance?

INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 received FDA 510(k) clearance on 2010-04-30, under 510(k) number K100939.

Who is the listed applicant for INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND 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 MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90?

The FDA product code for INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 is MHX.

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

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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.