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FDA 510(k)

Everion+ System

K-Number: K213863 · 2023-02-23

ApplicantBiofourmis Singapore Pte., Ltd.
Decision Date2023-02-23
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Everion+ System is the device name listed in this FDA 510(k) record. The listed applicant is Biofourmis Singapore Pte., Ltd.. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K213863. 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 Everion+ System?

Everion+ System is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Biofourmis Singapore Pte., Ltd.. The 510(k) number is K213863.

When did Everion+ System receive FDA 510(k) clearance?

Everion+ System received FDA 510(k) clearance on 2023-02-23, under 510(k) number K213863.

Who is the listed applicant for Everion+ System?

The FDA 510(k) record lists Biofourmis Singapore Pte., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Everion+ System?

The FDA product code for Everion+ System is MSX.

Other records listing Biofourmis Singapore Pte., Ltd. 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.

K233418Biofourmis Everion+ (G2)K183282Biovitals Analytics EngineK182344RhythmAnalytics

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.

K260211Dashboard (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.K242750Central StationNihon Kohden Digital Health Solutions, LLC

Official Source

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

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