FDA 510(k)

Handheld VitalSigns Monitoring System

N.º K: K172965 · 2018-12-17

Fecha de decisión2018-12-17

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Handheld VitalSigns Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Visiomed Technology Co.,Ltd. It received FDA 510(k) clearance on 2018-12-17 under 510(k) number K172965. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Handheld VitalSigns Monitoring System?

Handheld VitalSigns Monitoring System is a medical device that received FDA 510(k) clearance on 2018-12-17. The listed applicant is Visiomed Technology Co.,Ltd. The 510(k) number is K172965.

When did Handheld VitalSigns Monitoring System receive FDA 510(k) clearance?

Handheld VitalSigns Monitoring System received FDA 510(k) clearance on 2018-12-17, under 510(k) number K172965.

Who is the listed applicant for Handheld VitalSigns Monitoring System?

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

What is the FDA product code for Handheld VitalSigns Monitoring System?

The FDA product code for Handheld VitalSigns Monitoring System is MWI.

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: MWI)

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo Corporation K253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark Corporation K253436c-med0 alphaCosinuss GmbH K250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel Medical K241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.