FDA 510(k)

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber

Номер K: K240569 · 2024-11-21

Дата решения2024-11-21

Код продуктаCBF

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber is the device name listed in this FDA 510(k) record. The listed applicant is Fink Engineering Pty, Ltd.. It received FDA 510(k) clearance on 2024-11-21 under 510(k) number K240569. The device is classified under product code CBF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber?

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber is a medical device that received FDA 510(k) clearance on 2024-11-21. The listed applicant is Fink Engineering Pty, Ltd.. The 510(k) number is K240569.

When did FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber receive FDA 510(k) clearance?

FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber received FDA 510(k) clearance on 2024-11-21, under 510(k) number K240569.

Who is the listed applicant for FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber?

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

What is the FDA product code for FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber?

The FDA product code for FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber is CBF.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: CBF)

K220290Revitalair 430+Us Hyperbaric Network K171899Revitalair 430FOxavita Srl K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyOxyheal Medical Systems, Inc.K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control SystemOxyheal Medical Systems, Inc.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.