FDA 510(k)

Duet External Drainage and Monitoring System (EDMS)

Номер K: K242034 · 2024-10-24

Дата решения2024-10-24

Код продуктаPCB

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Duet External Drainage and Monitoring System (EDMS) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurosurgery. It received FDA 510(k) clearance on 2024-10-24 under 510(k) number K242034. The device is classified under product code PCB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Duet External Drainage and Monitoring System (EDMS)?

Duet External Drainage and Monitoring System (EDMS) is a medical device that received FDA 510(k) clearance on 2024-10-24. The listed applicant is Medtronic Neurosurgery. The 510(k) number is K242034.

When did Duet External Drainage and Monitoring System (EDMS) receive FDA 510(k) clearance?

Duet External Drainage and Monitoring System (EDMS) received FDA 510(k) clearance on 2024-10-24, under 510(k) number K242034.

Who is the listed applicant for Duet External Drainage and Monitoring System (EDMS)?

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

What is the FDA product code for Duet External Drainage and Monitoring System (EDMS)?

The FDA product code for Duet External Drainage and Monitoring System (EDMS) is PCB.

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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Другие записи, где Medtronic Neurosurgery указан как заявитель

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Официальный источник

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