FDA 510(k)

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200

Номер K: K223784 · 2023-04-18

Дата решения2023-04-18

Код продуктаGEI

Консультативный комитетSU

РешениеSubstantially Equivalent

Описание устройства

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 is the device name listed in this FDA 510(k) record. The listed applicant is Deltronix Equipamentos Ltda. It received FDA 510(k) clearance on 2023-04-18 under 510(k) number K223784. 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 Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 is a medical device that received FDA 510(k) clearance on 2023-04-18. The listed applicant is Deltronix Equipamentos Ltda. The 510(k) number is K223784.

When did Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 receive FDA 510(k) clearance?

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 received FDA 510(k) clearance on 2023-04-18, under 510(k) number K223784.

Who is the listed applicant for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

The FDA 510(k) record lists Deltronix Equipamentos Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

The FDA product code for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 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)

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Официальный источник

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