FDA 510(k)

CellFX Percutaneous Electrode System (SYS3000)

N.º K: K233705 · 2024-03-08

Fecha de decisión2024-03-08

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Pulse Biosciences, Inc. como solicitante

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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Fuente oficial

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