Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EVERON

K-Number: K082465 · 2009-03-25

ApplicantEarlysense, Ltd.
Decision Date2009-03-25
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EVERON is the device name listed in this FDA 510(k) record. The listed applicant is Earlysense, Ltd.. It received FDA 510(k) clearance on 2009-03-25 under 510(k) number K082465. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVERON?

EVERON is a medical device that received FDA 510(k) clearance on 2009-03-25. The listed applicant is Earlysense, Ltd.. The 510(k) number is K082465.

When did EVERON receive FDA 510(k) clearance?

EVERON received FDA 510(k) clearance on 2009-03-25, under 510(k) number K082465.

Who is the listed applicant for EVERON?

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

What is the FDA product code for EVERON?

The FDA product code for EVERON is BZQ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Earlysense, 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.

K171836EarlySense Bed Sensing UnitK152911EarlySense Insight SytemK131379EARLYSENSEK121885EARLYSENSE CENTRAL DISPLAY SYSTEMK120465EARLYSENSE (EVERON) SYSTEMK110521EVERON CENTRAL DISPLAY STATION (CDS)

View all 10 devices →

Related Devices (Code: BZQ)

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.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

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.

↑