FDA 510(k)

8ch Fio de R/T de Joelho

Número K: K223225 · 2023-02-14

Data da decisão2023-02-14

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

Outros registros que listam Shenzhen RF Tech Co., Ltd. como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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 Arranjo de Joelho (10-F34127)K2232031.5T 24E Arranjo Posterior K2232398ch Fio de Pulso

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Fonte oficial

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