FDA 510(k)

NES Reprocessed RF Stylet (RFS)

Número K: K173214 · 2018-03-27

RequerenteNortheast Scientific, Inc. (Nes)

Data da decisão2018-03-27

Código do produtoNUJ

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

NES Reprocessed RF Stylet (RFS) is the device name listed in this FDA 510(k) record. The listed applicant is Northeast Scientific, Inc. (Nes). It received FDA 510(k) clearance on 2018-03-27 under 510(k) number K173214. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NES Reprocessed RF Stylet (RFS)?

NES Reprocessed RF Stylet (RFS) is a medical device that received FDA 510(k) clearance on 2018-03-27. The listed applicant is Northeast Scientific, Inc. (Nes). The 510(k) number is K173214.

When did NES Reprocessed RF Stylet (RFS) receive FDA 510(k) clearance?

NES Reprocessed RF Stylet (RFS) received FDA 510(k) clearance on 2018-03-27, under 510(k) number K173214.

Who is the listed applicant for NES Reprocessed RF Stylet (RFS)?

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

What is the FDA product code for NES Reprocessed RF Stylet (RFS)?

The FDA product code for NES Reprocessed RF Stylet (RFS) is NUJ.

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