FDA 510(k)

Voyant 电外科发生器

K号: K182244 · 2018-10-11

决定日期2018-10-11

产品代码GEI

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决定实质等同

器械摘要

Voyant Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K182244. 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 Voyant Electrosurgical Generator?

Voyant Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K182244.

When did Voyant Electrosurgical Generator receive FDA 510(k) clearance?

Voyant Electrosurgical Generator received FDA 510(k) clearance on 2018-10-11, under 510(k) number K182244.

Who is the listed applicant for Voyant Electrosurgical Generator?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant Electrosurgical Generator?

The FDA product code for Voyant Electrosurgical Generator is GEI.

列明Applied Medical Resources Corp.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。

K252740Voyant® 开放融合设备（EB240/开放融合）K252442Kii结构球囊通路系统 K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device K201212Voyant 开放融合设备 K200598Voyant马里兰州融合设备 K193292Voyant 5mm 融合设备，Voyant 马里兰州融合设备

查看所有 11 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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