FDA 510(k)

OneTouch Via On-Demand Insulin Delivery System

Номер K: K163357 · 2017-06-07

ЗаявительLifescan Europe, A Division of Cilag GmbH

Дата решения2017-06-07

Код продуктаOPP

Консультативный комитетHO

РешениеSubstantially Equivalent

Описание устройства

OneTouch Via On-Demand Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K163357. The device is classified under product code OPP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the OneTouch Via On-Demand Insulin Delivery System?

OneTouch Via On-Demand Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Lifescan Europe, A Division of Cilag GmbH. The 510(k) number is K163357.

When did OneTouch Via On-Demand Insulin Delivery System receive FDA 510(k) clearance?

OneTouch Via On-Demand Insulin Delivery System received FDA 510(k) clearance on 2017-06-07, under 510(k) number K163357.

Who is the listed applicant for OneTouch Via On-Demand Insulin Delivery System?

The FDA 510(k) record lists Lifescan Europe, A Division of Cilag GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OneTouch Via On-Demand Insulin Delivery System?

The FDA product code for OneTouch Via On-Demand Insulin Delivery System is OPP.

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: OPP)

K252757CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA K243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA

Официальный источник

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