FDA 510(k)

Vesalius

Номер K: K152933 · 2016-03-23

ЗаявительTelea Electronic Engineering Srl

Дата решения2016-03-23

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Vesalius is the device name listed in this FDA 510(k) record. The listed applicant is Telea Electronic Engineering Srl. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K152933. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Vesalius?

Vesalius is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Telea Electronic Engineering Srl. The 510(k) number is K152933.

When did Vesalius receive FDA 510(k) clearance?

Vesalius received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152933.

Who is the listed applicant for Vesalius?

The FDA 510(k) record lists Telea Electronic Engineering Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vesalius?

The FDA product code for Vesalius is GEI.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: GEI)

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker Instruments K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364Ellian Enigma RF DeviceEllian Corp K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

Официальный источник

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