FDA 510(k)

embecta Insulin Delivery System

Номер K: K234027 · 2024-08-30

Дата решения2024-08-30

Код продуктаQFG

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

embecta Insulin Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Embecta Medical I, LLC. It received FDA 510(k) clearance on 2024-08-30 under 510(k) number K234027. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the embecta Insulin Delivery System?

embecta Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2024-08-30. The listed applicant is Embecta Medical I, LLC. The 510(k) number is K234027.

When did embecta Insulin Delivery System receive FDA 510(k) clearance?

embecta Insulin Delivery System received FDA 510(k) clearance on 2024-08-30, under 510(k) number K234027.

Who is the listed applicant for embecta Insulin Delivery System?

The FDA 510(k) record lists Embecta Medical I, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for embecta Insulin Delivery System?

The FDA product code for embecta Insulin Delivery System is QFG.

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: QFG)

K260001Mint ACE PumpBeta Bionics, Inc.K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and Development K253976iLet ACE PumpBeta Bionics, Inc.K253743MiniMed Flex pumpMedtronic Minimed, Inc.K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.

Официальный источник

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