FDA 510(k)

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts

Número K: K162460 · 2017-04-28

Data da decisão2017-04-28

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts is the device name listed in this FDA 510(k) record. The listed applicant is Wavi Co.. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K162460. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts?

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Wavi Co.. The 510(k) number is K162460.

When did WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts receive FDA 510(k) clearance?

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts received FDA 510(k) clearance on 2017-04-28, under 510(k) number K162460.

Who is the listed applicant for WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts?

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

What is the FDA product code for WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts?

The FDA product code for WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts is GXY.

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Fonte oficial

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