FDA 510(k)

CellFX Percutaneous Electrode System (SYS3000)

Número K: K233705 · 2024-03-08

Data da decisão2024-03-08

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CellFX Percutaneous Electrode System (SYS3000) is the device name listed in this FDA 510(k) record. The listed applicant is Pulse Biosciences, Inc.. It received FDA 510(k) clearance on 2024-03-08 under 510(k) number K233705. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CellFX Percutaneous Electrode System (SYS3000)?

CellFX Percutaneous Electrode System (SYS3000) is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Pulse Biosciences, Inc.. The 510(k) number is K233705.

When did CellFX Percutaneous Electrode System (SYS3000) receive FDA 510(k) clearance?

CellFX Percutaneous Electrode System (SYS3000) received FDA 510(k) clearance on 2024-03-08, under 510(k) number K233705.

Who is the listed applicant for CellFX Percutaneous Electrode System (SYS3000)?

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

What is the FDA product code for CellFX Percutaneous Electrode System (SYS3000)?

The FDA product code for CellFX Percutaneous Electrode System (SYS3000) is GEI.

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Outros registros que listam Pulse Biosciences, Inc. como candidato(a)

K240782CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode, 13G (CPE013); CellFX Percutaneous Electrode, 18G (CPE018)K213674CellFX System K222075CellFX System K221671CellFX® System K211444CellFX System K203299CellFX System

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Fonte oficial

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