FDA 510(k)

Olive Plus

Número K: K161981 · 2016-10-14

Data da decisão2016-10-14

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Olive Plus is the device name listed in this FDA 510(k) record. The listed applicant is Ama Network, Inc.. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161981. 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 Olive Plus?

Olive Plus is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Ama Network, Inc.. The 510(k) number is K161981.

When did Olive Plus receive FDA 510(k) clearance?

Olive Plus received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161981.

Who is the listed applicant for Olive Plus?

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

What is the FDA product code for Olive Plus?

The FDA product code for Olive Plus is GEX. This falls under the Gastroenterology category.

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