FDA 510(k)

WVSM Pro (Series) (500-0030-XX)

N.º K: K233354 · 2024-06-26

Fecha de decisión2024-06-26

Código de productoMWI

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

WVSM Pro (Series) (500-0030-XX) is the device name listed in this FDA 510(k) record. The listed applicant is Athena Gtx, Inc.. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K233354. 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 WVSM Pro (Series) (500-0030-XX)?

WVSM Pro (Series) (500-0030-XX) is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is Athena Gtx, Inc.. The 510(k) number is K233354.

When did WVSM Pro (Series) (500-0030-XX) receive FDA 510(k) clearance?

WVSM Pro (Series) (500-0030-XX) received FDA 510(k) clearance on 2024-06-26, under 510(k) number K233354.

Who is the listed applicant for WVSM Pro (Series) (500-0030-XX)?

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

What is the FDA product code for WVSM Pro (Series) (500-0030-XX)?

The FDA product code for WVSM Pro (Series) (500-0030-XX) 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.