FDA 510(k)

Resonic 快速聲學脈沖設備

K 號：K233804 · 2024-02-01

決定日期2024-02-01

產品代碼GEX

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

Resonic Rapid Acoustic Pulse Device is the device name listed in this FDA 510(k) record. The listed applicant is Zeltiq Aesthetics, Inc.. It received FDA 510(k) clearance on 2024-02-01 under 510(k) number K233804. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Resonic Rapid Acoustic Pulse Device?

Resonic Rapid Acoustic Pulse Device is a medical device that received FDA 510(k) clearance on 2024-02-01. The listed applicant is Zeltiq Aesthetics, Inc.. The 510(k) number is K233804.

When did Resonic Rapid Acoustic Pulse Device receive FDA 510(k) clearance?

Resonic Rapid Acoustic Pulse Device received FDA 510(k) clearance on 2024-02-01, under 510(k) number K233804.

Who is the listed applicant for Resonic Rapid Acoustic Pulse Device?

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

What is the FDA product code for Resonic Rapid Acoustic Pulse Device?

The FDA product code for Resonic Rapid Acoustic Pulse Device is GEX. This falls under the Gastroenterology category.

其他以 Zeltiq Aesthetics, Inc. 為申請人之記錄

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相關器械（代碼：GEX）

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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