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FDA 510(k)

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)

N.º K: K234108 · 2024-09-20

SolicitanteEnergy Resources International Co., Ltd.
Fecha de decisión2024-09-20
Código de productoIZL
Comité asesorRA
DecisiónSubstantially Equivalent

Resumen del dispositivo

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is the device name listed in this FDA 510(k) record. The listed applicant is Energy Resources International Co., Ltd.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K234108. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)?

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Energy Resources International Co., Ltd.. The 510(k) number is K234108.

When did ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) receive FDA 510(k) clearance?

ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) received FDA 510(k) clearance on 2024-09-20, under 510(k) number K234108.

Who is the listed applicant for ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)?

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

What is the FDA product code for ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E)?

The FDA product code for ERI Portable X-ray System (CVX-air); ERI Portable X-ray System (CVX-lite); ERI Portable X-ray System (CVX-E) is IZL.

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Dispositivos relacionados (Código: IZL)

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.

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Fuente oficial

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