FDA 510(k)

Soniquence 可重复使用 3 按钮 fingerswitch 手杖

K号: K212222 · 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

Soniquence Reusable 3 Button Fingerswitch Wand is the device name listed in this FDA 510(k) record. The listed applicant is Soniquence, LLC. It received FDA 510(k) clearance on 2022-09-02 under 510(k) number K212222. 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 Soniquence Reusable 3 Button Fingerswitch Wand?

Soniquence Reusable 3 Button Fingerswitch Wand is a medical device that received FDA 510(k) clearance on 2022-09-02. The listed applicant is Soniquence, LLC. The 510(k) number is K212222.

When did Soniquence Reusable 3 Button Fingerswitch Wand receive FDA 510(k) clearance?

Soniquence Reusable 3 Button Fingerswitch Wand received FDA 510(k) clearance on 2022-09-02, under 510(k) number K212222.

Who is the listed applicant for Soniquence Reusable 3 Button Fingerswitch Wand?

The FDA 510(k) record lists Soniquence, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Soniquence Reusable 3 Button Fingerswitch Wand?

The FDA product code for Soniquence Reusable 3 Button Fingerswitch Wand is GEI.

列明Soniquence, 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。

K254220可重复使用3按钮手指开关棒 K220071Soniquence 可重复使用中性板 K211946Soniquence 可重复使用双极电缆 K190336Soniquence 双极电极 K183611Soniquence RF 发生器和 Soniquence 电极

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。

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 K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC 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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