FDA 510(k)

8ch Suite Flexible

N.º K: K200836 · 2020-07-22

Fecha de decisión2020-07-22

Código de productoMOS

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

8ch Flex Suite 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 2020-07-22 under 510(k) number K200836. 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 Flex Suite?

8ch Flex Suite is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Shenzhen RF Tech Co., Ltd.. The 510(k) number is K200836.

When did 8ch Flex Suite receive FDA 510(k) clearance?

8ch Flex Suite received FDA 510(k) clearance on 2020-07-22, under 510(k) number K200836.

Who is the listed applicant for 8ch Flex Suite?

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 Flex Suite?

The FDA product code for 8ch Flex Suite is MOS.

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

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 K2232258ch Bobina de Rodilla T/R

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