FDA 510(k)

DIXI Medical Microdeep Micro-Macro Depth Electrodes

Número K: K202087 · 2021-11-18

Data da decisão2021-11-18

Código do produtoGZL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

DIXI Medical Microdeep Micro-Macro Depth Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Dixi Medical. It received FDA 510(k) clearance on 2021-11-18 under 510(k) number K202087. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DIXI Medical Microdeep Micro-Macro Depth Electrodes?

DIXI Medical Microdeep Micro-Macro Depth Electrodes is a medical device that received FDA 510(k) clearance on 2021-11-18. The listed applicant is Dixi Medical. The 510(k) number is K202087.

When did DIXI Medical Microdeep Micro-Macro Depth Electrodes receive FDA 510(k) clearance?

DIXI Medical Microdeep Micro-Macro Depth Electrodes received FDA 510(k) clearance on 2021-11-18, under 510(k) number K202087.

Who is the listed applicant for DIXI Medical Microdeep Micro-Macro Depth Electrodes?

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

What is the FDA product code for DIXI Medical Microdeep Micro-Macro Depth Electrodes?

The FDA product code for DIXI Medical Microdeep Micro-Macro Depth Electrodes is GZL.

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Outros registros que listam Dixi Medical como candidato(a)

K201931Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)K170959DIXI Medical Microdeep Depth Electrode

Dispositivos Relacionados (Código: GZL)

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