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 CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0

K-Number: K100376 · 2010-08-06

ApplicantEarlysense, Ltd.
Decision Date2010-08-06
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 is the device name listed in this FDA 510(k) record. The listed applicant is Earlysense, Ltd.. It received FDA 510(k) clearance on 2010-08-06 under 510(k) number K100376. 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 EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0?

EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 is a medical device that received FDA 510(k) clearance on 2010-08-06. The listed applicant is Earlysense, Ltd.. The 510(k) number is K100376.

When did EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 receive FDA 510(k) clearance?

EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 received FDA 510(k) clearance on 2010-08-06, under 510(k) number K100376.

Who is the listed applicant for EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0?

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 CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0?

The FDA product code for EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0 is MSX.

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: 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.

↑