FDA 510(k)

Resonic 快速声脉冲装置

K号: K233804 · 2024-02-01

决定日期2024-02-01

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Zeltiq Aesthetics, Inc.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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