FDA 510(k)

8ch Bobina de Rodilla T/R

N.º K: K223225 · 2023-02-14

Fecha de decisión2023-02-14

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

8ch T/R Knee Coil is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen RF Tech Co., Ltd.. It received FDA 510(k) clearance on 2023-02-14 under 510(k) number K223225. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 8ch T/R Knee Coil?

8ch T/R Knee Coil is a medical device that received FDA 510(k) clearance on 2023-02-14. The listed applicant is Shenzhen RF Tech Co., Ltd.. The 510(k) number is K223225.

When did 8ch T/R Knee Coil receive FDA 510(k) clearance?

8ch T/R Knee Coil received FDA 510(k) clearance on 2023-02-14, under 510(k) number K223225.

Who is the listed applicant for 8ch T/R Knee Coil?

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

What is the FDA product code for 8ch T/R Knee Coil?

The FDA product code for 8ch T/R Knee Coil is MOS.

Otros registros que enlistan a Shenzhen RF Tech Co., Ltd. como solicitante

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.

K252587HD 8Ch Wrist Array K252876GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only K252179GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only K2310851.5T HD T/R Knee Array (10-F34127)K2232031.5T 24E Posterior Array K2232398ch Bobina de Muñeca

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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.