FDA 510(k)

Fidmi Low Profile Enteral Feeding Device

Номер K: K191844 · 2019-09-30

Дата решения2019-09-30

Код продуктаKGC

Консультативный комитетGU

РешениеSubstantially Equivalent

Описание устройства

Fidmi Low Profile Enteral Feeding Device is the device name listed in this FDA 510(k) record. The listed applicant is Fidmi Medical, Ltd.. It received FDA 510(k) clearance on 2019-09-30 under 510(k) number K191844. The device is classified under product code KGC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Fidmi Low Profile Enteral Feeding Device?

Fidmi Low Profile Enteral Feeding Device is a medical device that received FDA 510(k) clearance on 2019-09-30. The listed applicant is Fidmi Medical, Ltd.. The 510(k) number is K191844.

When did Fidmi Low Profile Enteral Feeding Device receive FDA 510(k) clearance?

Fidmi Low Profile Enteral Feeding Device received FDA 510(k) clearance on 2019-09-30, under 510(k) number K191844.

Who is the listed applicant for Fidmi Low Profile Enteral Feeding Device?

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

What is the FDA product code for Fidmi Low Profile Enteral Feeding Device?

The FDA product code for Fidmi Low Profile Enteral Feeding Device is KGC.

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: KGC)

K242211PUMA-G Pediatric SystemCoaptech, Inc.K223916PUMA-G SystemCoaptech, Inc.K193612AMT Система доставки швовApplied Medical Technology, Inc.K182832Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor SetCook Incorporated K183057PUMA-G SystemCoaptech, LLC K170323Entuit Start Initial Placement Gastrostomy SetCook Incorporated

Официальный источник

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