FDA 510(k)

Automated ankle brachial pressure index measuring device, MESI mTABLET system

N.º K: K201046 · 2020-12-11

SolicitanteMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

Fecha de decisión2020-12-11

Código de productoJOM

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Automated ankle brachial pressure index measuring device, MESI mTABLET system is the device name listed in this FDA 510(k) record. The listed applicant is Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K201046. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Automated ankle brachial pressure index measuring device, MESI mTABLET system?

Automated ankle brachial pressure index measuring device, MESI mTABLET system is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. The 510(k) number is K201046.

When did Automated ankle brachial pressure index measuring device, MESI mTABLET system receive FDA 510(k) clearance?

Automated ankle brachial pressure index measuring device, MESI mTABLET system received FDA 510(k) clearance on 2020-12-11, under 510(k) number K201046.

Who is the listed applicant for Automated ankle brachial pressure index measuring device, MESI mTABLET system?

The FDA 510(k) record lists Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automated ankle brachial pressure index measuring device, MESI mTABLET system?

The FDA product code for Automated ankle brachial pressure index measuring device, MESI mTABLET system is JOM.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. como solicitante

K172655Automated ankle brachial pressure index measuring device

Dispositivos relacionados (Código: JOM)

K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix K213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc.K191266VitalScan ANSMedeia, Inc.K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K173696TBL-ABI SystemLd Technology, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.