FDA 510(k)

CellFX经皮电极系统（SYS3000）

K号: K233705 · 2024-03-08

决定日期2024-03-08

产品代码GEI

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决定实质等同

器械摘要

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.

常见问题

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.

列明Pulse Biosciences, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K240782CellFX经皮电极系统（SYS3000）；CellFX经皮电极，13G（CPE013）；CellFX经皮电极，18G（CPE018）K213674CellFX系统 K222075CellFX系统 K221671CellFX®系统 K211444CellFX系统 K203299CellFX系统

查看所有 7 个设备 →

相关器械（代码：GEI）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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