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FDA 510(k)

M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00

K-Number: K081983 · 2008-08-22

ApplicantPhilips Medical Systems
Decision Date2008-08-22
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems. It received FDA 510(k) clearance on 2008-08-22 under 510(k) number K081983. 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 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00?

M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 is a medical device that received FDA 510(k) clearance on 2008-08-22. The listed applicant is Philips Medical Systems. The 510(k) number is K081983.

When did M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 receive FDA 510(k) clearance?

M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 received FDA 510(k) clearance on 2008-08-22, under 510(k) number K081983.

Who is the listed applicant for M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00?

The FDA 510(k) record lists Philips Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00?

The FDA product code for M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 is MHX.

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Other records listing Philips Medical Systems as applicant

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.

K212704Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound SystemK211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemK210560Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 CardiographK191738PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 CardiographK192875Philips Biosensor BX100K183387M3290B Patient Information Center iX

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Related Devices (Code: MHX)

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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.

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