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FDA 510(k)

INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00

K-Number: K102974 · 2011-01-04

ApplicantPhilips Medical Systems
Decision Date2011-01-04
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 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 2011-01-04 under 510(k) number K102974. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00?

INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 is a medical device that received FDA 510(k) clearance on 2011-01-04. The listed applicant is Philips Medical Systems. The 510(k) number is K102974.

When did INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 receive FDA 510(k) clearance?

INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 received FDA 510(k) clearance on 2011-01-04, under 510(k) number K102974.

Who is the listed applicant for INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00?

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 INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00?

The FDA product code for INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00 is MSX.

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Other records listing Philips Medical Systems as applicant

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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: MSX)

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.

K261287Digistat CareAscom Ums Srl UnipersonaleK260211Dashboard (P007000)Hill-Rom, Inc.K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.K253654IntelliVue Measurement Rack 6000 (867317)Philips Medizin Systeme Böblingen GmbHK243270TigerConnect Alarm ManagementTigerconnectK242728BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

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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