FDA 510(k)

Bare: 808

Número K: K193446 · 2020-03-10

RequerenteLuvo Medical Technologies, Inc.

Data da decisão2020-03-10

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Bare: 808 is the device name listed in this FDA 510(k) record. The listed applicant is Luvo Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-03-10 under 510(k) number K193446. 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 Bare: 808?

Bare: 808 is a medical device that received FDA 510(k) clearance on 2020-03-10. The listed applicant is Luvo Medical Technologies, Inc.. The 510(k) number is K193446.

When did Bare: 808 receive FDA 510(k) clearance?

Bare: 808 received FDA 510(k) clearance on 2020-03-10, under 510(k) number K193446.

Who is the listed applicant for Bare: 808?

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

What is the FDA product code for Bare: 808?

The FDA product code for Bare: 808 is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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