FDA 510(k)

Resonic Rapid Acoustic Pulse Device

Número K: K233804 · 2024-02-01

Data da decisão2024-02-01

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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