FDA 510(k)

Soniquence 可重用 3 鈕手指開關棒

K 號：K212222 · 2022-09-02

決定日期2022-09-02

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Soniquence, LLC 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：GEI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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