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FDA 510(k)

CareEvent inclusive of the CareEvent Mobile Application accessory

K-Number: K161164 · 2016-06-24

ApplicantPhilips Medical Systems
Decision Date2016-06-24
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CareEvent inclusive of the CareEvent Mobile Application accessory is a medical device manufactured by Philips Medical Systems. It received FDA 510(k) clearance on 2016-06-24 under approval number K161164. 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 CareEvent inclusive of the CareEvent Mobile Application accessory?

CareEvent inclusive of the CareEvent Mobile Application accessory is a medical device that received FDA 510(k) clearance on 2016-06-24. It is manufactured by Philips Medical Systems. The 510(k) number is K161164.

When was CareEvent inclusive of the CareEvent Mobile Application accessory approved by the FDA?

CareEvent inclusive of the CareEvent Mobile Application accessory received FDA 510(k) clearance on 2016-06-24, under approval number K161164.

What company makes CareEvent inclusive of the CareEvent Mobile Application accessory?

CareEvent inclusive of the CareEvent Mobile Application accessory is manufactured by Philips Medical Systems.

What is the FDA product code for CareEvent inclusive of the CareEvent Mobile Application accessory?

The FDA product code for CareEvent inclusive of the CareEvent Mobile Application accessory is MSX.

Related Clinical Trials

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Related PubMed Literature

PMID: 37873612 A European regulatory pathway for Tidepool loop following clearance in the United States? Diabetic medicine : a journal of the British Diabetic Association (2024) PMID: 32342744 Mobile Research Applications and State Research Laws. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2020) PMID: 25644202 Regulatory frameworks for mobile medical applications. Expert review of medical devices (2015)

Other Devices by Philips Medical Systems

K153702M3290B Philips IntelliVue Information Center iX K160951Philips Efficia CMS200 Central Monitoring System K151812PATIENT MONITORS VARIOUS MODELS K172226MX40 Release B.07 K163584M3290B Philips IntelliVue Information Center iX K163649SureSigns VS3; SureSigns VS4

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Related Devices (Code: MSX)

K153156eCareManager 4.0.1Visicu, Inc. K160862AirStrip RPMAirstrip Technologies, Inc. K171322eCareManager 4.1Visicu, Inc. K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K180430Digistat Smart CentralAscom Ums Srl Unipersonale K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter PackageSnap40, 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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