FDA 510(k)

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)

Номер K: K234153 · 2024-09-18

Дата решения2024-09-18

Код продуктаIYN

Консультативный комитетRA

РешениеSubstantially Equivalent

Описание устройства

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is the device name listed in this FDA 510(k) record. The listed applicant is Edgelife Technologies, LLC. It received FDA 510(k) clearance on 2024-09-18 under 510(k) number K234153. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is a medical device that received FDA 510(k) clearance on 2024-09-18. The listed applicant is Edgelife Technologies, LLC. The 510(k) number is K234153.

When did EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) receive FDA 510(k) clearance?

EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) received FDA 510(k) clearance on 2024-09-18, under 510(k) number K234153.

Who is the listed applicant for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

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

What is the FDA product code for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220)?

The FDA product code for EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) is IYN.

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: IYN)

Официальный источник

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