FDA 510(k)

Cabeça de Eletródio de Headset PressOn

Número K: K190801 · 2019-07-10

Data da decisão2019-07-10

Código do produtoGXZ

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PressOn Electrode Headset is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmlink International, LLC. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K190801. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PressOn Electrode Headset?

PressOn Electrode Headset is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K190801.

When did PressOn Electrode Headset receive FDA 510(k) clearance?

PressOn Electrode Headset received FDA 510(k) clearance on 2019-07-10, under 510(k) number K190801.

Who is the listed applicant for PressOn Electrode Headset?

The FDA 510(k) record lists Rhythmlink International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PressOn Electrode Headset?

The FDA product code for PressOn Electrode Headset is GXZ.

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Outros registros que listam Rhythmlink International, LLC como candidato(a)

K203079MR Conditional Sticky Pad Electrode K200984Guardian Needle Electrode K191225EEG Electrode Template K172503MR Conditional Cup Electrode, MR Conditional Webb Electrode

Dispositivos Relacionados (Código: GXZ)

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Fonte oficial

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