FDA 510(k)

EZYPRO ECG Recorder (Model: UG02)

N.º K: K213233 · 2022-06-23

Fecha de decisión2022-06-23

Código de productoDRG

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

EZYPRO ECG Recorder (Model: UG02) is the device name listed in this FDA 510(k) record. The listed applicant is Sigknow Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-23 under 510(k) number K213233. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EZYPRO ECG Recorder (Model: UG02)?

EZYPRO ECG Recorder (Model: UG02) is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Sigknow Biomedical Co., Ltd.. The 510(k) number is K213233.

When did EZYPRO ECG Recorder (Model: UG02) receive FDA 510(k) clearance?

EZYPRO ECG Recorder (Model: UG02) received FDA 510(k) clearance on 2022-06-23, under 510(k) number K213233.

Who is the listed applicant for EZYPRO ECG Recorder (Model: UG02)?

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

What is the FDA product code for EZYPRO ECG Recorder (Model: UG02)?

The FDA product code for EZYPRO ECG Recorder (Model: UG02) is DRG.

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

Dispositivos relacionados (Código: DRG)

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLC K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare Corporation K243837iBSMIorbit Digital Technologies Private Limited K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc.

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.