FDA 510(k)

NR Recorder

Número K: K161062 · 2016-06-13

Data da decisão2016-06-13

Código do produtoMWJ

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

NR Recorder is the device name listed in this FDA 510(k) record. The listed applicant is Norav Medical GmbH. It received FDA 510(k) clearance on 2016-06-13 under 510(k) number K161062. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NR Recorder?

NR Recorder is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Norav Medical GmbH. The 510(k) number is K161062.

When did NR Recorder receive FDA 510(k) clearance?

NR Recorder received FDA 510(k) clearance on 2016-06-13, under 510(k) number K161062.

Who is the listed applicant for NR Recorder?

The FDA 510(k) record lists Norav Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NR Recorder?

The FDA product code for NR Recorder is MWJ.

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Dispositivos Relacionados (Código: MWJ)

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