FDA PMA

Automated external defibrillators (non-wearable)

Номер PMA: P160032 · 2026-08-25

ЗаявительDefibtech, LLC

Дата решения2026-08-25

Номер PMAP160032

Код продуктаMKJ

Класс устройстваКласс 3

Медицинская специализацияC

Номер регулирования21 CFR 8

Консультативный комитетCV

Описание устройства

Automated external defibrillators (non-wearable) is the device name listed in this FDA 510(k) record. The listed applicant is Defibtech, LLC. It received FDA 510(k) clearance on 2026-08-25. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements.

Часто задаваемые вопросы

What is the Automated external defibrillators (non-wearable)?

Automated external defibrillators (non-wearable) is a medical device that received FDA 510(k) clearance on 2026-08-25. The listed applicant is Defibtech, LLC.

When did Automated external defibrillators (non-wearable) receive FDA 510(k) clearance?

The clearance date for Automated external defibrillators (non-wearable) can be found in the official FDA records.

Who is the listed applicant for Automated external defibrillators (non-wearable)?

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

What is the FDA product code for Automated external defibrillators (non-wearable)?

The FDA product code for Automated external defibrillators (non-wearable) is MKJ. This falls under the Dental category.

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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Официальный источник

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