FDA 510(k)

CellFX系统

K号: K222075 · 2022-09-02

决定日期2022-09-02

产品代码GEI

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决定实质等同

器械摘要

CellFX System 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 2022-09-02 under 510(k) number K222075. 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 System?

CellFX System is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Pulse Biosciences, Inc.. The 510(k) number is K222075.

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

CellFX System received FDA 510(k) clearance on 2022-09-02, under 510(k) number K222075.

Who is the listed applicant for CellFX System?

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 System?

The FDA product code for CellFX System 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）K233705CellFX经皮电极系统（SYS3000）K213674CellFX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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

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