FDA 510(k)

Valleylab REM 聚合婴儿患者返回电极

K号: K160290 · 2016-05-19

决定日期2016-05-19

产品代码GEI

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决定实质等同

器械摘要

Valleylab REM Polyhesive Infant Patient Return Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, LLC. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K160290. 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 Valleylab REM Polyhesive Infant Patient Return Electrode?

Valleylab REM Polyhesive Infant Patient Return Electrode is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Covidien, LLC. The 510(k) number is K160290.

When did Valleylab REM Polyhesive Infant Patient Return Electrode receive FDA 510(k) clearance?

Valleylab REM Polyhesive Infant Patient Return Electrode received FDA 510(k) clearance on 2016-05-19, under 510(k) number K160290.

Who is the listed applicant for Valleylab REM Polyhesive Infant Patient Return Electrode?

FDA 510(k)记录中列出Covidien, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Valleylab REM Polyhesive Infant Patient Return Electrode?

The FDA product code for Valleylab REM Polyhesive Infant Patient Return Electrode is GEI.

列明Covidien, LLC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。

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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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