FDA 510(k)

HD 8Ch Wrist Array

Número K: K252587 · 2026-04-14

Data da decisão2026-04-14

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

HD 8Ch Wrist Array 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 2026-04-14 under 510(k) number K252587. 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 HD 8Ch Wrist Array?

HD 8Ch Wrist Array is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Shenzhen RF Tech Co., Ltd.. The 510(k) number is K252587.

When did HD 8Ch Wrist Array receive FDA 510(k) clearance?

HD 8Ch Wrist Array received FDA 510(k) clearance on 2026-04-14, under 510(k) number K252587.

Who is the listed applicant for HD 8Ch Wrist Array?

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 HD 8Ch Wrist Array?

The FDA product code for HD 8Ch Wrist Array is MOS.

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

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 K2232258ch Fio de R/T de Joelho K2232398ch Fio de Pulso

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Dispositivos Relacionados (Código: MOS)

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Fonte oficial

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