FDA 510(k)

DuoFLEX Coil Suite

Número K: K173290 · 2017-11-28

Data da decisão2017-11-28

Código do produtoMOS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

DuoFLEX Coil Suite is the device name listed in this FDA 510(k) record. The listed applicant is Mr Instruments, Inc.. It received FDA 510(k) clearance on 2017-11-28 under 510(k) number K173290. 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 DuoFLEX Coil Suite?

DuoFLEX Coil Suite is a medical device that received FDA 510(k) clearance on 2017-11-28. The listed applicant is Mr Instruments, Inc.. The 510(k) number is K173290.

When did DuoFLEX Coil Suite receive FDA 510(k) clearance?

DuoFLEX Coil Suite received FDA 510(k) clearance on 2017-11-28, under 510(k) number K173290.

Who is the listed applicant for DuoFLEX Coil Suite?

The FDA 510(k) record lists Mr Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuoFLEX Coil Suite?

The FDA product code for DuoFLEX Coil Suite is MOS.

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