FDA 510(k)

TraumaGuard Intra-abdominal Pressure Sensing System

Номер K: K210570 · 2021-10-29

ЗаявительSentinel Medical Technologies, LLC

Дата решения2021-10-29

Код продуктаPHU

РешениеSubstantially Equivalent

Описание устройства

TraumaGuard Intra-abdominal Pressure Sensing System is the device name listed in this FDA 510(k) record. The listed applicant is Sentinel Medical Technologies, LLC. It received FDA 510(k) clearance on 2021-10-29 under 510(k) number K210570. The device is classified under product code PHU. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the TraumaGuard Intra-abdominal Pressure Sensing System?

TraumaGuard Intra-abdominal Pressure Sensing System is a medical device that received FDA 510(k) clearance on 2021-10-29. The listed applicant is Sentinel Medical Technologies, LLC. The 510(k) number is K210570.

When did TraumaGuard Intra-abdominal Pressure Sensing System receive FDA 510(k) clearance?

TraumaGuard Intra-abdominal Pressure Sensing System received FDA 510(k) clearance on 2021-10-29, under 510(k) number K210570.

Who is the listed applicant for TraumaGuard Intra-abdominal Pressure Sensing System?

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

What is the FDA product code for TraumaGuard Intra-abdominal Pressure Sensing System?

The FDA product code for TraumaGuard Intra-abdominal Pressure Sensing System is PHU.

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 Sentinel Medical Technologies, LLC указан как заявитель

K240057TraumaGuard Intra-abdominal Pressure Sensing System

Официальный источник

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